INCIDENCE AND DETERMINANTS OF UNDESIRABLE EFFECTS FOLLOWING IRON AND FOLIC ACID SUPPLEMENTATION Evidence from the Weekly Iron and Folic Acid Supplementation Programme for Adolescents in Delhi and Haryana United Nations Children´s Fund India Country Office UNICEF House 73, Lodi Estate New Delhi 110003 Telephone: +91 11 24690401 www.unicef.in All rights reserved ©United Nations Children’s Fund (UNICEF) 2014 Cover photo: ©UNICEF India/Divakar Mani Suggested citation: United Nations Children’s Fund (UNICEF). Incidence and determinants of undesirable effects following iron and folic acid supplementation. Evidence from the Weekly Iron and Folic Acid Supplementation Programme for adolescents in Delhi and Haryana. Nutrition Reports, Issue 3, 2014. New Delhi: UNICEF, 2014. INCIDENCE AND DETERMINANTS OF UNDESIRABLE EFFECTS FOLLOWING IRON AND FOLIC ACID SUPPLEMENTATION Evidence from the Weekly Iron and Folic Acid Supplementation Programme for Adolescents in Delhi and Haryana Nutrition Reports, Issue 3, 2014 Notice: This discussion paper is a part of the UNICEF India nutrition discussion paper series containing preliminary material and research results. The nutrition discussion papers have been internally reviewed, but have not been subject to a formal external review. They are circulated in order to stimulate discussion and critical comment. This discussion paper has been shared with the Adolescent Health Division, Ministry of Health and Family Welfare, Government of India, on 7 February 2014. CONTENTS SUMMARY.................................................................. 5 Introduction.................................................................. 6 Methods....................................................................... 6 Results......................................................................... 7 Conclusion.................................................................... 8 REPORT...................................................................... 11 Introduction................................................................ 12 Methods..................................................................... 12 Results....................................................................... 16 Discussion.................................................................. 21 Conclusion.................................................................. 23 Literature cited........................................................... 25 STATISTICAL TABLES.............................................. 27 ANNEXES.................................................................. 45 ACKNOWLEDGEMENTS......................................................50 ©UNICEF India/Divakar Mani SUMMARY INTRODUCTION METHODS In January 2013, the Ministry of Health and Family Welfare (MHFW), Government of India, launched the nationwide Weekly Iron and Folic Acid Supplementation (WIFS) programme. The WIFS programme includes adolescent boys and girls of Class VI–XII in government, government-aided and municipal schools. It also covers out-of-school adolescent girls through the Integrated Child Development Services platform of the Ministry of Women and Child Development. The study was cross-sectional and conducted across government schools in three districts each in Delhi and Haryana that reported the highest incidence of undesirable effects in May 2013 (Haryana) and July 2013 (Delhi). Thirty schools from each state were selected utilizing 30-cluster Probability Proportional to Size (PPS) methodology. In total, 4,183 adolescents (1,980 boys and 2,203 girls) from 60 schools were covered. Respondents were adolescent boys and girls from Class VI-XII. However, as only Class VI-VIII were covered in the WIFS programme in Delhi, only these classes were covered in the Delhi sample. Additionally, 49 nodal teachers and 29 health providers were interviewed. When WIFS roll-out began at state level, many states reported that adolescents were complaining about undesirable effects after consuming iron folic acid tablets (IFA) and this was hampering the programme significantly through negative peer-to-peer pressure, mass hysteria and media reports. The latter brought the WIFS programme in Delhi and Haryana to near standstill after the administration of the first dose of WIFS in Haryana (in May 2013) and in Delhi (in July 2013). Upon the re-launch of WIFS in September 2013 in the two aforesaid states, upon request of the MHFW, UNICEF India was commissioned a study to answer the following four research questions: 1. What is the incidence of undesirable effects among school-going adolescent boys and girls in Delhi and Haryana? 2. Do the adolescent boys and girls who experience an undesirable effect vs. those who do not differ socio-demographically and nutritionally? 3. Are schools and health providers prepared to avert and manage undesirable effects? 4.What are the programme lapses that can be avoided to improve WIFS programme performance? 6 Summary The data collection period was 15-30 September 2013 in Haryana and 15-30 October 2013 in Delhi. Areas of enquiry included socio-demographic characteristics, consumption of iron folic acid (IFA) tablets, protocol followed and undesirable effects on first consumption and in last two consumptions. Nutritional status was ascertained through anthropometry – height, weight and mid-upper arm circumference (MUAC), and height-for-age (HAZ) and body mass index (BMI)-for-age z-scores were calculated using World Health Organization Anthroplus software. BMI-for-age z-score <-3SD was taken as severe thinness and BMI-for-age z-score <-2SD as thinness. Similarly, HAZ score <-3SD was taken as severe stunting and <-2SD as stunting. MUAC cut-off of <16 cm and <18.5 cm were considered severely thin and thin respectively. Dietary diversity was ascertained using a seven-day qualitative food frequency questionnaire. Information on perceived gaps in IFA administration and suggestions to bridge the gaps were collected from nodal teachers and medical officers. Appropriate analysis was done using STATA 12 (STATA Corporation, College Station, TX, USA). P values <0.05 were considered statistically significant. Tests of diagnostic accuracy were conducted to assess sensitivity and specificity of MUAC compared to BMI-for-age as the gold standard. RESULTS A total of 4,183 adolescents (1,980 boys and 2,203 girls) aged 10-19 years formed the analytical sample. The most important findings from the study are summarized in this section. RESEARCH QUESTION 1 What is the incidence of undesirable effects among school-going adolescents in Delhi and Haryana? The incidence of undesirable effects following IFA in the three weeks of WIFS administration (week 1: first consumption; week 2 and 3: two most recent consumptions) is discussed here. In week 1, out of 4,183 adolescents who were given IFA, 3,568 (85%) consumed IFA. Out of the 3,568 adolescents who consumed an IFA tablet, 907 (25%) reported that they faced an undesirable effect. Importantly, 410 out of the 907 adolescents (45%) who faced an undesirable effect in week 1 did not consume IFA in the subsequent week (week 2). Interestingly, 694 out of the 2,661 adolescents (26%) who did not face any undesirable effect in week 1 did not take IFA in week 2. In week 2, again when IFA was administered to all 4,183 adolescents, 2,630 (63%) reported that they consumed IFA – a drop of 18 percentage points in IFA consumption compared to 85% in week 1. But out of those who consumed IFA (n: 2,630), 7% reported an undesirable effect. Again, 80 out of 194 (41%) adolescents who faced an undesirable effect in week 2 did not consume IFA in week 3. Also, 685 of the 2,435 adolescents (28%) who did not face an undesirable effect did not consume IFA in week 3. In week 3 i.e., most recent consumption, again IFA was administered to all 4,183 adolescents. Out of these, 2,181 (52%) reported consuming IFA – a drop of 24 percentage points from week 2, although an overall reported incidence of undesirable effects was 5%. Thus, the incidence of undesirable effects in week 1, 2 and 3 was 25%, 7% and 5%, respectively. But the proportion of adoles- cents consuming IFA gradually decreased each subsequent week from 85% to 63% to 52% in week 1, 2 and 3, respectively. Importantly, 354 out of the 907 adolescents (39%) who faced an undesirable effect on first consumption discontinued IFA. Taking all three weeks, 1,050 adolescents faced an undesirable effect: 88% faced it only once, 8% twice and only 4% faced an undesirable effect on all three consumptions. The types of undesirable effects were abdominal pain (80%), nausea (10%), dizziness (8%) and fever (2%). Of the adolescents who reported undesirable effects two or more times – 90% had consumed the IFA tablet on an empty stomach, 72% had chewed the tablet and 85% had not had it with water. It is important to note that 18% adolescents in the two states did not eat anything before coming to school. Majority of the adolescents (85% boys and 87% girls) walked to school daily. The mean travel distance to school was 1.7 km. RESEARCH QUESTION 2 Do the adolescent boys and girls who experience an undesirable effect vs. those who do not differ sociodemographically and nutritionally? The prevalence of thinness i.e., BMI-for-age z-score <-2SD was 30% among boys and 23% among girls. One quarter of adolescent boys and girls were stunted (HAZ <-2SD). Multinomial regression analysis showed that the risk of undesirable effects was higher in girls, in lower classes (Class VI-VIII), and in urban residents, where parents, teachers and peers did not encourage IFA consumption, and when IFA was not consumed according to protocol. Having a BMI-for-age z-score <-2SD or HAZ <-2SD or coming from a poorer family were not significantly associated with facing undesirable effects. Adjusted binary logistic regression showed that positive pressure from parents, teachers and peers increased the odds of full compliance (of IFA) by nearly twofold, irrespective of the occurrence of an undesirable effect. Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 7 CONCLUSION RESEARCH QUESTION 3 Are schools and health providers prepared to avert and manage undesirable effects? In conclusion, undesirable effects significantly hamper the WIFS programme but are not influenced by poverty or nutritional status. Particular attention is to be paid to: No. Half of the teachers interviewed in Haryana and 5% teachers in Delhi did not receive training before roll-out of the WIFS programme. On the day of supplementation, only 43% teachers discussed the protocol on how to consume the tablet. In case of undesirable effects, 20% schools did not have any designated official/ team to handle the undesirable effects. As a preparedness exercise to manage undesirable effects, 37% of schools had provision of common medicines, in 29% schools the nodal teacher had contact details of the Emergency Response System team, and 20% teachers were aware of the WIFS emergency toll free helpline number, but none used it. 1. Constant positive reinforcement through multiple channels and preparedness to handle undesirable effects. Regular counselling by teachers and health providers to parents and peers can improve IFA compliance. At school, information on benefits and correct protocol should be disseminated through loud speakers, posters and visually attractive educational sessions (possibly through engagement of those who consume IFA regularly and can advocate its benefits). RESEARCH QUESTION 4 What are the programme lapses that can be avoided to improve WIFS programme performance? Programmatic lapses identified in performance of the WIFS programme as perceived by teachers and medical officers were: (i) suboptimal training of teachers, (ii) teachers themselves not being convinced of benefits of IFA administration, (iii) schools lacking ownership of the programme, feeling it is the job of the Department of Health, (iv) ineffective convergence between Departments of Health and Education, (v) inadequate positive media publicity and engaging with media only when an undesirable effect takes place, (vi) adolescents not liking the taste (and taking it mostly because teachers have asked them to), (vii) too much focus on IFA rather than addressing anaemia, (viii) long meal gaps for most adolescents, who mostly came from deprived families (did not eat anything before coming to school and had a diet which was poor in diversity), (ix) negative publicity by parents and peers after occurrence of the undesirable effect, and (x) panic in schools to manage undesirable effects. 8 Summary At community level, informative television or radio spots and positive messages through youth icons may be considered for reaching out to adolescents and their families. Use of mobile communication may also be considered. Information to raise awareness of helpline numbers, medicines and ‘WHAT TO DO’ when there are reported undesirable effects should be displayed in schools, and one day prior to IFA administration, all arrangements for emergency response should be re-checked by the emergency response team. 2. Following WIFS protocol matters. Majority of the adolescents who faced undesirable effects were those who did not follow the protocol. Hence, reinforcing the protocol is important. Although nutritional and socio-economic status did not influence the occurrence of undesirable effects, given that a large proportion of adolescents came from deprived families, walked to school and had a poor diet, provision of a nutrientdense snack to all adolescents may be considered so that no adolescent consumes IFA on an empty stomach. A nutrient-dense snack will also bridge the calorie-protein gap. Importantly, no adolescent should be missed from WIFS if they are not covered under the mid-day meal programme. 3. Convergence between Departments of Health and Education needs strengthening. Inter-sectoral collaboration and accountability mechanisms need to be strengthened. Presently, a large proportion of teachers have not received training on the WIFS programme. If they have, they are not equipped to manage undesirable effects and do not own the programme. 4.Test alternative iron supplementation methods. Compliance of IFA supplementation decreased each subsequent week from 85% in week 1 to 52% in week 3. This means that despite all effects, 48% of adolescents were not consuming the tablet in week 3. These findings suggest the need for experimenting more likeable energy dense iron-rich food supplements, which not only provide iron, but also bridge the gap in dietary macronutrient intake. 5. Ideally all schools should have World Health Organization BMI-for-age charts to assess progress on nutritional status. Until then, MUAC appears as a reasonable field alternative, subject to more diagnostic accuracy studies in other settings. Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 9 ©UNICEF India/Divakar Mani REPORT INTRODUCTION Adolescent anaemia is a public health problem in India. Every second adolescent girl and every third adolescent boy is anaemic in India1. Given the adverse consequences of adolescent anaemia on growth, resistance to infections, cognitive development and work productivity, preventing adolescent anaemia is a high priority agenda for the Indian government2. After 13 years of evidence generation by UNICEF on the use of weekly iron and folic acid supplementation to address anaemia in adolescent girls in different Indian states, the Ministry of Health and Family Welfare (MHFW), Government of India, launched a nationwide Weekly Iron and Folic Acid Supplementation (WIFS) programme in January 2013. The WIFS programme includes both adolescent boys and girls enrolled in Class VI–XII in government, government-aided and municipal schools. It also covers ‘out-of-school’ adolescent girls through the Integrated Child Development Services platform of the Ministry of Women and Child Development3. The WIFS programme has four components: 1. Supervised WIFS comprising 100 mg of elemental iron and 500 mcg of folic acid (IFA). 2. Screening for moderate/severe anaemia and referral to nearest health facility. 3. Deworming prophylaxis (400 mg albendazole) six months apart for the prevention of helminthic infestations. 4.Monthly nutrition and health education (NHE) to encourage consumption of locally available iron-rich foods and prevent helminthic infestations. Global research shows that there are unintended but expected mild undesirable effects following IFA consumption. These include gastrointestinal discomfort (stomach ache and nausea) and change in the colour of stool. Studies show that the proportion of adolescent girls who experience undesirable effects following IFA consumption varies from 5% to 20%4. When the universal WIFS programme roll-out began in various Indian states, state programme managers in charge of the roll-out 12 Report in many states reported that adolescents were complaining about undesirable effects after consuming iron and folic acid tablets and this was hampering the programme significantly through negative peer-to-peer pressure, mass hysteria and media reports. The latter brought the WIFS programme in the states of Delhi and Haryana to near standstill after the administration of the first dose of IFA in May 2013 in Haryana and July 2013 in Delhi. Questions arose among state programme managers whether adolescents who are weak socio-economically and nutritionally are more likely to experience undesirable effects and should the IFA dose be reduced for them. Upon the relaunch of WIFS in September 2013 in the two aforesaid states, and upon request of the MHFW, UNICEF India was commissioned a study to answer the following four research questions: 1. What is the incidence of undesirable effects among school-going adolescent boys and girls? 2. Do the adolescent boys and girls who experience an undesirable effect vs. those who do not differ socio-demographically and nutritionally? 3. Are schools and health providers prepared to avert and manage undesirable effects? 4. What are the programme lapses that can be avoided to improve WIFS programme performance? METHODS The present study was school-based, crosssectional and followed 30-cluster Probability Proportional to Size (PPS) methodology. Setting States: The geographical scope of the study was the National Capital Territory of Delhi and Haryana – home to 5.3 million and 3.3 million adolescent boys and girls, respectively5. Delhi and Haryana were selected as they reported the highest number of undesirable effects following administration of the first dose of IFA after the launch of the WIFS programme in these states (May 2013 in Haryana and July 2013 in Delhi). institutions. The team was trained on the tools and techniques used for data collection by the UNICEF lead focal point for the study. The tools were pre-tested on 5% of the sample in a school in West Delhi. Districts: In consultation with state governments and the national and state programme teams of the WIFS programme, the top three districts where the WIFS programme was operational in September 2013 and from where the maximum number of undesirable effects following the first dose of IFA supplementation were reported in May 2013 (Haryana) and July 2013 (Delhi) were selected. In Delhi, the three districts were West A, West B and South West B. In Haryana, Hissar, Jind and Jhajjar districts were chosen. Respondents and sample size: A sample size of 2,049 was calculated for each state using maximum reported incidence of undesirable effects of 20%3, relative precision of 15%, 95% confidence interval and design effect of 3 (see Annex 4). The respondents were adolescent boys and girls from Class VI-XII covered under the WIFS programme. Only Class VI-VIII were included in the Delhi survey as only these classes were covered in the WIFS programme here. From each school (which is considered as a cluster in the present study), at least 70 adolescents were included. An attempt was made to include at least five boys and girls from each class. Adolescents were selected randomly from each class to complete minimum sample size. Schools: The study was restricted to government schools, which fall under the jurisdiction of the state government’s Directorate of Education, as majority of the undesirable effects were reported from government schools. The list of schools was obtained by the state Department of Health and Family Welfare from the Directorate of Education. All the schools were enlisted with their respective populations. Thirty schools from each state were selected utilizing the 30-cluster PPS method. The details of the 30-cluster PPS method are given in Annex 1. The list of the 30 schools selected from the two states is given in Annexes 2 and 3. Survey weeks were decided in consultation with district medical officers, the school health programme division and school principal. However, the exact date was not told to the school administration until the eve of data collection to ensure accuracy in the collection. Written consent from the school authorities was taken prior to the survey. Data collection The nodal teacher of the WIFS programme from each school and at least one primary health medical officer responsible for the Emergency Response System (ERS) for the block in which the school was situated were also interviewed. In total, 4,183 adolescents (1,980 boys and 2,203 girls) from 60 schools, 49 nodal teachers and 29 health providers formed the sample. The graphical presentation of research design is shown in Figure 1. The data collection period was 15-30 September 2013 in Haryana and 15-30 October 2013 in Delhi. Information and assessments: Two methods were used for collection of data from the adolescents – interview method and assessment of nutritional status using dietary and anthropometric methods. Nodal teachers and medical officers were interviewed using a structured interview schedule and verbal consent was taken from all the respondents. The team: A team was formed comprising two doctoral researchers trained in nutrition epidemiology and 15 postgraduate nutrition students from the nutrition department of two academic Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 13 Information gathered from and assessments conducted on adolescent boys and girls i. Adolescent characteristics: The information gathered included class, age (in completed years), residence (urban/rural), mode, distance and time taken to reach the school, and whether any form of employed work (paid or unpaid) is carried out by the adolescent before/after coming to school. From adolescent girls, information on onset of menses, availability and use of sanitary pads, availability of free sanitary pads in schools (which were provided free of cost in Delhi) and use of cotton/cloth during menses was also collected. ii. Family characteristics: The study included information on the number of siblings, family size, education level and occupation of mother and father. Household characteristics were also enquired and included source of drinking water and toilet facility, material of flooring and roof (as per definitions used in India’s National Family Health Survey 31), number of persons per sleeping room, availability of communication media like radio, television, mobiles and computers, type of cooking fuel used and availability of ration card. iii.Anthropometry measurements6: Three types of anthropometric measurements – height, weight and mid-upper arm circumference (MUAC) were done on all the adolescents. Height was measured to nearest 0.1 cm using a wall-mounted microtoise, nailed on a wall with no or minimum skirting. Adolescents stood barefoot on a flat floor with heels together, calves, buttocks, shoulder and head in one straight vertical line touching the wall. They were asked to keep legs straight and shoulders relaxed. The head was comfortably positioned in Frankfurt plane, that is, lower body of the orbit of the eye in same horizontal plane as the external canal of the ear and arms hanging loosely on the sides. The head- 14 Report piece of the microtoise was gently lowered and slight pressure was applied, making contact with top of head to record the height. Weight was recorded to nearest 0.1 kg using an electronic weighing balance (TANITA scale model no. H0358). Weight was taken barefoot with minimal clothing while standing straight on the weighing scale without any support. Weighing scales were calibrated daily using standard weight of 1 and 5 kg before taking the first observation. Mid-upper arm circumference was measured to nearest 0.1 cm using a nonstretchable standard MUAC tape (provided by UNICEF). The left arm of the adolescent was bent at the elbow at 90-degree angle, with upper arm held parallel to the side of the body. The distance between tip of acromion and olecranon process was measured and mid-point was marked. The adolescent was then asked to let the arm loose and the upper arm at the mid-point was measured, making sure the tape was not tight. iv. Dietary assessment: A seven-day qualitative food frequency questionnaire was administered to assess consumption of foods from different food groups, especially ironrich foods. The food frequency questionnaire included nine food groups, namely, cereals (including roots and tubers), dark green leafy vegetables (DGLV), vitamin-C rich fruits, organ meats, meats, eggs, pulses and milk. Each food group was assigned 1 score to calculate the dietary diversity score (scores were in the range of 0-9)7. Respondents were enquired about the meal consumed before coming to school on survey day. v. IFA consumption, undesirable effects and receipt of other services of the WIFS programme: Respondents were asked to recall IFA administration of three weeks to determine the consumption pattern of IFA. Three weeks included first consumption when the programme was first initiated (May 2013 for Haryana and July 2013 for Delhi) and last Figure 1 Research design States with highest prevalence of undesirable effects Delhi Haryana 3 districts West A West B South West B 3 districts Hissar Jind Jhajjar Maximum cases of undesirable side effects 30 schools Boys (N=1,063) Girls (N=1,070) 30 schools Boys (N=917) Teachers (N=22) MO (N=13) Girls (N=1,133) Teachers (N=27) MO (N=16) Interview with adolescents: Socio-demographic profile, nutritional assessment, consumption pattern of IFA, incidence of undesirable effects and benefits of IFA consumption. Interview with MOs and teachers: Emergency response system on occurrence of undesirable effects. Data analysis MS Excel (Office 10), WHO Anthroplus version 1.0.4, SPSS version 16.0 Report writing MO = medical officer two consumptions from the day of enquiry (September 2013 in Haryana and October 2013 in Delhi). Information on the WIFS protocol being followed, that is, IFA intake on full stomach, swallowed with full glass of water and supervised administration by the nodal teacher was also collected. The following information was collected on experience of undesirable effects after each of the three IFA consumptions: type of undesirable effects and perceived reasons. Information was also asked on reasons for consuming or not con- suming the IFA tablet. Information was also collected about receipt of two other services under the WIFS programme – receipt of biannual dose of albendazole and monthly nutrition and health education in school. Interview with nodal teachers and health providers The nodal teacher responsible for IFA administration in each school (n: 49) and the medical officer of the nearest Primary Health Centre/ Dispensary (n: 29) to the school responsible for Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 15 emergency response were interviewed. Data on training received for IFA administration (teachers only), protocol for IFA administration, reporting of undesirable effects, preparedness for adverse effects and actions taken in case of undesirable effects were collected from teachers and medical officers. Information on perceived gaps in IFA administration and suggestions to bridge those gaps were also collected. (state, sex, residence and deprivation index), anthropometry (BMI-for-age z-score, HAZ, MUAC less than 16 cm and 18.5 cm), dietary profile (not eating anything before coming to school and dietary diversity score), enabling factors for IFA consumption (peer, parents’ and teachers’ influence), self-efficacy and protocols followed for IFA consumption (supervised IFA consumption, full stomach, with water and swallowed). Statistical analysis The statistical significance of the bivariate association was assessed using chi-square test. The net association of undesirable effects with significant variables was examined in a step-wise multinomial logistic regression. Associations of compliance (intake of at least two IFA) with socio-demographic characteristics, undesirable effects and promoters of IFA consumption were also studied using chi-square for bivariate and multivariate logistic regression analysis. P values <0.05 were considered statistically significant. The collected data were consolidated in Microsoft Excel (2007). The consolidated data were rechecked for completeness and accuracy. Height was used to calculate height-for-age z-score (HAZ) and body mass index (BMI)-for-age z-score was calculated using height and weight measurements. World Health Organization Anthroplus (version 1.0.4)8 software was used for calculating z-scores. BMI-for-age z-score cut-off point of <-3SD was taken as severe thinness and <-2SD as thinness (which included severe thinness). Similarly, HAZ cut-off point of <-3SD was taken as severe stunting and <-2SD as stunting (which included severe stunting). MUAC cut-off of <16 cm and <18.5 cm were considered severely thin and thin, respectively9. A multidimensional index of deprivation was used to determine deprivation (proxy: for poverty). It included seven components – adolescent BMI-for-age z-score <-2SD, non-improved drinking water facility, no toilet facility at home, no access to health facility, illiteracy or less than primary literacy among adolescents, ≥3 household members living in one room and no exposure to media, that is, non-availability of newspapers, radio, television, computers or mobiles at home. Deprivation threshold score of 2-3 indicates moderate poverty and 4-7 indicates severe deprivation. Such a multidimensional index of deprivation has been used elsewhere10. Analysis was done using STATA 12 (STATA Corporation, College Station, TX, USA). First, standard univariate descriptive statistics were calculated. Then, bivariate associations of undesirable effects (no undesirable effects, undesirable effects faced once and faced two or more times) was done with adolescent characteristics 16 Report To estimate the diagnostic accuracy between BMI-for-age z-scores and MUAC, BMI-for-age was considered as the gold standard and sensitivity, specificity, positive and negative predictive values and likelihood ratios were calculated. To compare agreement between the two methods, kappa statistic was calculated. Association between the absolute values of BMI-for-age z-scores and MUAC was determined by Pearson correlation (r) method11. RESULTS All the 4,183 adolescents in Class VI to XII in the study were included in the analysis. Of these, 1,980 were adolescent boys and 2,203 were adolescent girls. In Delhi, the sampled adolescents were from Class VI-VIII, given that only beneficiaries of the mid-day meal scheme were given an IFA tablet. In Haryana, IFA was being provided to adolescents in Class VI-XII. 1. What were the background characteristics of the adolescents? Table 1 describes the profile of the sampled adolescents. Over 90% of the Haryana sam- Figure 2 Mean BMI-for-age z-scores 10-12 13-15 16-19 Mean BMI-for-age z-score -1.05 -1.1 -1.15 -1.2 n=2094 -1.25 -1.3 n=1632 -1.35 -1.4 n=457 Age range (in completed years) ple resided in rural areas and nearly 90% of the Delhi sample resided in urban areas. The majority of the adolescents (85% boys and 87% girls) walked to school daily in both states. The mean travel distance to school was 1.7 km. Out of 4,183 adolescents, 88 (2%) also worked in a job along with regular schooling. Of these 88 adolescents who worked, 56 (64%) worked without pay. Among adolescent girls, 41% had started menstruating (31% in Delhi and 50% in Haryana). Out of the girls who started menstruating, 76% girls used sanitary napkins (96% in Delhi and 64% in Haryana). In Delhi, 85% of the girls were using sanitary napkins as they were available free of cost from school, under the School Health Programme; no such programme was operational in Haryana. In Haryana, 64% of the girls used sanitary pads, while 36% used cotton/cloth. 2. What were the socio-economic characteristics of the adolescents? About 50% of the mothers of the sampled adolescents were illiterate and at least three quarters of them were not engaged in working outside the home. In contrast, most (≈60%) fa- thers of the sample adolescents had received education up to middle and higher level schooling and were engaged in skilled work. Homes from where the adolescents came from were mostly pucca or made of high quality (≈80%). However, this proportion was lower in Haryana (≈66%) compared to Delhi (≈90%). According to the multidimensional index of deprivation, in both states, three quarters adolescents were from moderately deprived and 13% were from severely deprived families (see Table 2). 3. What was the nutritional status of the adolescents? Thinness: The prevalence of thinness i.e., BMI-for-age z-score <-2SD was 30% among boys and 23% among girls (see Table 3). The sex-wise differences were starker in Delhi (boys: 29% vs. girls: 19%) compared to Haryana (boys: 31% vs. girls: 26%). Over 9% boys and 6% girls were severely thin i.e., BMI-forage z-score <-3SD. As age increased, mean BMI-for-age z- score worsened (see Figure 2). The prevalence of thinness and severe thinness also increased with increasing age (see Table 4). As household deprivation increased, mean BMI-for-age z-score also worsened (see Figure 3). Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 17 Stunting: One quarter of adolescent boys and girls were stunted (HAZ <-2SD) (see Table 3). Proportion of severely stunted adolescents i.e., HAZ <-3SD was 6%. Stunting increased steeply from 9% in age of 10 years to 32% in age group of 18-19 years in boys. Among girls, stunting was highest in the age group of 11-12 years and 14 years (see Table 4). Identifying at-risk adolescents using MUAC: Almost one third (29%) adolescent boys and 26% adolescent girls had a MUAC less than 18.5 cm. Proportion of adolescent boys and girls with MUAC less than 16 cm was 7% and 6%, respectively. Dietary pattern: Almost one fifth (18%) adolescents in the two states did not eat anything before coming to school (see Table 3). This proportion was higher in Haryana in comparison to Delhi (21% vs. 16%) and higher in girls compared to boys (23% vs. 13%). Not even half of the sampled adolescents consumed iron-rich foods twice a week. Diet diversity was low, as 49% of the adolescents were consuming fewer than three food groups in a day. Consumption of eggs and meat twice a week was also low (<15%). Meals chiefly comprised a cereal and pulse/vegetable. Consumption of DGLVs and vitamin C rich fruits at least twice a week was 42% and 31%, respectively. Diagnostic accuracy of MUAC compared to BMI-for-age z-score (as gold standard): There was agreement in 3,246 out of 4,183 (78%) observations of MUAC < 18.5 cm with BMI-forage z-score <-2SD. Kappa value of 0.34 (95% CI 0.31-0.38) showed a moderate agreement between the two tests. With BMI-for-age z-score <-2SD as the gold standard, sensitivity and specificity by MUAC <18.5 cm to correctly identify thinness (true-positive) and non-thinness (true negative) was 73% and 79%, respectively (see Table 5). When MUAC <16 cm was compared with BMIfor-age z-score <-3SD (as gold standard), there was agreement in 3,959 out of 4,183 (95%) observations, kappa value was 0.38 (95% CI 0.310.38) but sensitivity and specificity of MUAC 18 Report <16 cm method to correctly identify severely thinness (true-positive) and non-severely thinness (true negative) was 63% and 97% (see Table 5). Taking absolute value of MUAC (in cm) and BMI-for-age z-score, the power of association between MUAC and BMI-for-age z-score was strong (r value of 0.68 (p<0.001)). 4. What was the IFA consumption and compliance to protocol? Table 6 describes the consumption pattern of IFA during the first week of WIFS administration i.e., in May 2013 (Haryana) and July 2013 (Delhi) and the last two weeks preceding the survey, a total of three consumptions. The proportion of adolescents who consumed IFA only once, twice and all three times were 23%, 26% and 42%, respectively (see Table 6). The protocol for IFA consumption is that it is to be supervised, after a meal, with water and swallowed (not chewed). Overall 43% adolescents reported supervised IFA consumption (67% in Haryana and 47% in Delhi). Percentage of adolescents consuming IFA on an empty stomach was low, but higher in Haryana compared to Delhi, and few but yet more adolescents in Haryana chewed IFA than in Delhi (see Table 6). Since the universal rollout of the WIFS programme, albendazole had been given once in both states, and it was consumed by two thirds of the adolescents. One third of adolescent girls mentioned receiving at least one nutrition and health education session. Attendance in NHE was higher in Haryana compared to Delhi (37% vs. 27%) and higher in girls compared to boys (34% vs. 29%). 5. What was the incidence of undesirable effects following IFA consumption? The incidence of undesirable effects in each of the three weeks of WIFS administration (week 1: first consumption, week 2 and week 3 i.e., two most recent consumptions) is presented in Table 7. In week 1, out of 4,183 adolescents who were given IFA, 3,568 (85%) consumed IFA. Out of the 3,568 adolescents who consumed an IFA Figure 3 Association of BMI-for-age z-score with multidimensional index of poverty Non-poor Moderately poor Severely poor Mean BMI-for-age z-score 0 -0.5 -0.6 -1 -1.2 -1.5 -2 -2.1 -2.5 Multidimensional index of poverty tablet, 907 (25%) reported that they faced an undesirable effect. Interestingly, 410 out of the 907 adolescents (45%) who faced an undesirable effect in week 1 did not consume IFA in the subsequent week (week 2). Also, 694 out of 2,661 adolescents (26%) who did not even face any undesirable effect in week 1 did not take IFA in week 2, on influence of their peers. In week 2, again when IFA was administered to all 4,183 adolescents, 2,630 (63%) reported that they consumed IFA – a drop of 18 percentage points in IFA consumption compared to 85% in week 1. But out of those who consumed IFA (n: 2,630), 7% reported to have faced an undesirable effect. Again, 80 out of 194 (41%) of adolescents who faced an undesirable effect in week 2 did not consume IFA in week 3. Also, 685 of the 2,435 adolescents (28%) who did not face an undesirable effect did not consume IFA in week 3. In week 3 i.e., most recent consumption, again IFA was administered to all 4,183 adolescents. Out of these, 2,181 (52%) reported consuming IFA – a drop of 24 percentage points from week 2, although the overall reported prevalence of undesirable effects was only 5%. Thus, incidence of undesirable effects in week 1, 2 and 3 was 25%, 7% and 5%, respectively. But the proportion of adolescents consuming IFA gradually decreased each subsequent week from 85% to 63% to 52% in week 1, 2 and 3, respectively. Importantly, 410 out of the 907 adolescents (45%) who faced an undesirable effect in week 1 did not consume IFA in the subsequent week (week 2) and 354 of the 410 did not have IFA in week 3. This means that 354 out of the 907 adolescents (39%) who faced an undesirable effect on first consumption discontinued taking IFA tablets. Taking all three weeks, 1,050 adolescents faced an undesirable effect: 88% faced it only once, 8% twice and only 4% faced an undesirable effect on all three consumptions. The types of undesirable effects were abdominal pain (80%), nausea (10%), dizziness (8%) and fever (2%). When the 1,050 adolescents who faced an undesirable effect were asked the perceived reasons for it (see Table 7), 37% said because the body had not adjusted to the tablet, 16% mentioned because they did not follow the protocol and 2% mentioned that it was due to menses. Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 19 6. What factors affected full compliance of IFA? Table 8 describes the characteristics of the adolescents who demonstrated full IFA compliance (i.e., consumed IFA in all three weeks) compared to those who consumed IFA either in week 1 or 2. Full compliance was significantly higher in Haryana compared to Delhi (53% vs. 47%, p<0.001), in girls compared to boys (54% vs. 46%, p=0.04) and in rural compared to urban adolescents (60% vs. 43%, p=0.001). Adjusted binary logistic regression showed that a high self-efficacy and positive pressure from parents, teachers and peers increased the odds of full compliance by 1.4-2.0-fold (see Table 8), irrespective of the occurrence of the undesirable effect. High self-efficacy meant that the adolescents themselves felt that the tablet is beneficial to them. Most commonly perceived benefits were that they felt healthier (28%), felt energetic (16%), and did not fall sick (17%) (see Table 9). 7. Did the adolescents who experienced an undesirable effect vs. those who did not differ socio-demographically and nutritionally? Table 10 shows the proportion of adolescents who faced undesirable effects at least twice significantly differed by state (2% in Delhi vs. 4% in Haryana, p=0.001), gender (32% in males vs. 69% in females, p=0.001) and class (58% in Class VI-VIII vs. 42% in Class IX-XII, p=0.001). Having a BMI-for-age z-score <-2SD or HAZ <-2SD or coming from a poorer family were not significantly associated with facing undesirable effects two or more times. Regression analysis (see Table 12) confirmed that risk of facing undesirable effects was twofold higher in girls, in lower classes (Class VI-VIII), urban residents, where peers and parents did not encourage IFA consumption, and when IFA was not consumed according to protocol. 8. Were teachers prepared to avert and manage undesirable effects? More than half of the teachers interviewed in Haryana and 5% teachers in Delhi did not re- 20 Report ceive training before roll-out of the WIFS programme (see Table 13). Twelve per cent of the schools did not have a teacher designated as a nodal teacher in-charge of the WIFS programme. On the day of supplementation, only 43% teachers discussed the protocol on how to consume the tablet. In case of undesirable effects, 20% schools did not have any designated official/team to handle the undesirable effects. As a preparedness exercise to manage undesirable effects, 37% of schools had provision of common medicines, in 29% schools the nodal teacher had contact details of the ERS team, and 20% teachers were aware of the WIFS emergency toll free helpline number, but none used it. In Haryana, there was no helpline number. 9. Were health providers prepared and equipped to manage undesirable effects? Approximately two thirds (66%) health providers interviewed reported that contact details of hospitals and an ERS team were made available to schools and common medicines were also at the schools’ disposal (see Table 14). At least 80% of medical officers interviewed reported that an ambulance was available on the day of IFA administration in the health facility. The main causes of undesirable effects amongst adolescents reported by medical officers were not following protocol (62%) and domino effect (48%). Surprisingly, 59% of them felt that adolescents who are undernourished or anaemic are more likely to face an undesirable effect. 10.Which programme lapses could have been avoided to improve WIFS programme performance? Programmatic lapses identified in the performance of the WIFS programme as perceived by teachers and medical officers were: i. suboptimal training of teachers; ii. teachers themselves not being convinced of benefits of IFA administration; iii.schools lacking ownership of the programme, feeling it is the job of the Department of Health; iv. ineffective convergence between Departments of Health and Education; v. inadequate positive media publicity and engaging with media only when an undesirable effect takes place; vi.adolescents not liking the taste (and taking it mostly because teachers have asked them to rather than willingness to have the tablet); vii. too much focus on the IFA tablet instead of raising awareness on the harms of anaemia and the role IFA consumption plays in preventing anaemia. viii. long meal gaps for most adolescents, who mostly came from deprived families (did not eat anything before coming to school and had diet which was poor in diet diversity); ix. negative publicity by parents and peers after occurrence of undesirable effects; and x. lack of preparedness and panic in schools to manage undesirable effects. DISCUSSION The 10 most important findings that emerged from this study are discussed in this section. 1. In Delhi, adolescents in Class IX-XII were not receiving WIFS. After the re-launch of the WIFS programme in September 2013, Delhi schools administrated IFA to only Class VI-VIII (younger adolescents) after the mid-day meal. IFA was not being distributed to adolescents in Class IX-XII, as it was felt that older adolescents reported more undesirable effects and were more likely to take the tablet on an empty stomach. Programme implication: According to NFHS-3, 56% girls and 30% boys aged 15-19 years are anaemic in India1. Nonadministration of IFA in Class IX-XII misses a large number of anaemic girls aged 15-19 years, who should be provided WIFS. 2. Nearly one fifth of adolescents (23% girls and 13% boys) did not eat anything before coming to school and 85% adolescents walked at least 1.5 km to school. Nearly one fifth of adolescents came to school on an empty stomach. In any case, the diets consumed by the adolescents were sub-optimal in diet diversity and low in iron-rich foods. Adolescents who reported not consuming anything before coming to school were 1.2 times more likely to report facing undesirable effects (OR 1.3, 95% CI 1.0-1.5). Also, 90% of adolescents who reported experiencing undesirable effects two or more times consumed the tablet on an empty stomach. Programme implication: There is a need to sensitize adolescents on the importance of eating before going to school. Provision of a nutrient-dense snack to all adolescents may be considered so that no adolescent consumes IFA on an empty stomach. The school assembly platform should be tapped to spread awareness on the harms of anaemia and benefits of IFA. 3. Incidence of undesirable effects reduced gradually but adversely affected compliance. In the first consumption, 25% adolescents faced an undesirable effect, which reduced to 7% and 5% in subsequent consumptions. The most common undesirable effect was stomach ache. However, the overall consumption of IFA reduced from 85% in week 1 to 52% in week 3 due to negative media publicity, negative parental and peer pressure (which was more in urban areas and among girls) and ill preparedness of schools to manage undesirable effects. Importantly, 40% of adolescents who faced an undesirable effect in week 1 did not have IFA in week 2 and week 3. Programme implication: Regular IFA consumption reduces incidence of undesirable effects as among those adolescents who consumed IFA and faced undesirable effects, 88% faced them only once. However, mass hysteria adversely affected WIFS in both states and reduced the motivation among teachers and health providers who administer the tab- Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 21 lets. Focus on positive media publicity, and positive engagement of parents and peers needs to be accelerated in the WIFS programme. 4. Reported undesirable effects were higher among girls and urbanites. The reported odds of undesirable effects were twofold higher in girls compared to boys (adjusted OR = 2.2, 95% CI 1.5 to 3.3). Adolescents in rural areas were less likely to report undesirable effects (adjusted OR 0.5, 95% CI 0.3-0.9). Programme implication: Adolescent girls who have benefited from IFA should be encouraged to become peer monitors to motivate others. Positive video and audio communication materials may be played through the school central speaker system and through mass and mid media so that there is a positive discussion and dialogue around addressing anaemia and the positive role of IFA among peers, parents and providers. 5. Nutritional status was not a predictor of undesirable effects. One quarter of adolescents were stunted and 27% were thin (BMI-for-age z-score <-2SD). Thinness, severe thinness and stunting were not significantly associated with occurrence of undesirable effects. Programme implication: Nutritional status of the adolescents does not affect the occurrence of undesirable effects. Thus, there is no need to reduce the IFA dosage for adolescents who are thin or stunted. However, given that a large proportion of adolescents are thin and stunted, there is a need to accelerate measures for improving their nutritional status. 6. Socio-economic status was not a predictor of undesirable effects. According to the multidimensional deprivation index, 87% school-going adolescents were moderately/severely deprived. However, socioeconomic status did not emerge as a significant predictor of undesirable effects. 22 Report Programme implication: Socio-economic status is not associated with undesirable effects among adolescents. However, focus needs to be made on ensuring these children receive a mid-morning snack as their dietary practices at home are poor. 7. Not following protocols was a significant predictor of undesirable effects. Consumption of IFA without water (adjusted OR 16.4, CI 4.1-66.5), on an empty stomach (adjusted OR 50.3, CI 5.9-116.9) and chewing the tablet (adjusted OR 4.03, CI 2.3-5.95) increased the odds of facing undesirable effects. Programme implication: Not following WIFS protocols was a significant predictor of undesirable effects. Worryingly, in only 50% schools these protocols were reinforced on the day of administration of IFA. Teachers should be instructed to repeat the protocols a day prior and on the day of administration of IFA. Provisions can be made to provide a mid-day meal in case some adolescents forget to bring lunch to school. 8. Schools were not prepared to avert and manage undesirable effects. One third of the teachers did not receive training before the roll-out of the WIFS programme. Schools and teachers felt that the programme was an added responsibility. More than half of the schools did not reinforce the protocol while administering IFA. Awareness of the helpline number and its use, and disseminating important information about what do in the event of an undesirable effect was very low. Programme implications: Collaboration with the Department of Education is essential to improve IFA administration, ensure nodal teachers are trained and monitored to ensure undesirable effects are averted and managed as well as ensure students are provided information on the types of undesirable effects, counselled on what to do and who to go to when such effects happen to avoid panic. CONCLUSION 9. Parental and peer pressure influenced compliance and undesirable effects. Negative parental and peer pressure increased the odds of undesirable effects by at least threefold (OR 3.4, CI 2.3-5.1). Positive peer influence increased compliance by 1.4 times (OR 1.4, CI 1.2-1.7) and also reduced the odds of reporting undesirable effects (OR 0.6, CI 0.5-10). Both these factors increased the self-efficacy of the adolescent. Programme implication: Positive environment was identified as an important determinant for IFA consumption and reducing undesirable effects. Parents and peers should be made the focus of communication strategies on IFA and informed about the benefits of IFA as well as possible undesirable effects and their management. 10.MUAC appeared as a promising field-based method for identifying at-risk adolescents. More evidence is needed on its use. Kappa value of 0.34 (95% CI, 0.31-0.38) for BMI-for-age z-score <-2SD and MUAC <18.5 cm and 0.38 (95% CI, 0.31-0.38) for BMI-forage z-score <-3SD and MUAC <16 cm showed a moderate agreement between the two methods of assessing nutritional status, that is, BMI (gold standard) and MUAC. Other studies comparing diagnostic accuracy of MUAC against BMI also found that MUAC has a moderate to good agreement with BMI12,13. Programme implication: In settings where weighing scales, height meters and BMI-for-age charts are not available, simple methods such as MUAC may be used to identify adolescents at risk and institute corrective measures for them. These may include providing them an additional snack/supplement, enrolling them for extra diet and counselling sessions, which would include improving dietary habits, confidence building and supplementary feeding. In conclusion, undesirable effects significantly hamper the WIFS programme but are not influenced by socio-economic or nutritional status. Particular attention is to be paid to: 1. Positive reinforcement and preparedness to handle undesirable effects matter. Regular counselling by teachers and health providers to parents and adolescents can improve IFA compliance. At school, information should be disseminated through loud speakers, posters and visually attractive educational sessions (possibly through engagement of those who consume IFA regularly and can advocate its benefits). At community level, informative television or radio spots, through youth icons, may be considered for reaching out to adolescents and their families. Information to raise awareness on helpline numbers, medicines and ‘WHAT TO DO’ when there are reported undesirable effects should be displayed in schools, and one day prior to IFA administration, all arrangements for emergency response should be re-checked by the emergency response team. 2. Following WIFS protocol matters. On the day of IFA distribution, it is essential to ensure that the adolescents have a meal before consuming the IFA tablet. The availability of safe water for swallowing IFA should be ensured on school premises. Adolescents should be informed about anaemia, the positive benefits of IFA along with possible undesirable effects, which may reduce with subsequent IFA consumption. Although nutritional status and socioeconomic status did not influence undesirable effects, given that a large proportion of adolescents came from deprived families, walked to school and had a poor diet, provision of a nutrient-dense snack to all adolescents may be considered so that no adolescent consumes IFA on an empty stomach. There is a need to sensitize adolescents on the importance of consuming Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 23 meals before going to school. All platforms for promoting WIFS should also promote improved dietary practices. 3. Convergence between Departments of Health and Education needs strengthening. Inter-sectoral collaboration and accountability mechanisms need to be strengthened at all levels. Presently a large proportion of teachers have not received training on WIFS. If they have, they are not equipped to manage undesirable effects and do not own the programme. 4.Test alternative iron supplementation methods. Compliance of IFA supplementation decreased each subsequent week from 85% in week 1 to 52% in week 3. 24 Report This means that despite all effects, 48% of adolescents were not consuming the tablet. These findings suggest the need for experimenting to find more likeable energy dense iron-rich food supplements, which not only provide iron, but also supplement recommended macronutrients. Large-scale studies on efficacy, feasibility and effectiveness of use of alternative food supplementation products on haemoglobin levels are still to be carried out. 5.Ideally all schools should have BMIfor-age charts to assess progress on nutritional status. Until then, MUAC appears as a reasonable field alternative, subject to more diagnostic accuracy studies in other settings. LITERATURE CITED 1 International Institute for Population Sciences (IIPS) and Macro International. National Family Health Survey (NFHS-3), 2005-06. Mumbai: International Institute for Population Sciences, 2007. http://www. measuredhs.com/pubs/pdf/FRIND3/FRIND3-VOL2.pdf. Accessed 1 September 2013. 2 World Health Organization. Nutrition in adolescence – issues and challenges for the health sector. Geneva: World Health Organization, 2005. http://whqlibdoc.who.int/publications/2005/9241593660_ eng.pdf. Accessed 14 January 2014. 3 Ministry of Health and Family Welfare. Operational framework: weekly iron folic acid supplementation programme for adolescents. New Delhi: Government of India, 2012. http://tripuranrhm.gov.in/Guidlines/ WIFS.pdf. Accessed 1 September 2013. 4 World Health Organization. Weekly iron and folic acid supplementation programmes for women of reproductive age. An analysis of best programme practices. Geneva: World Health Organization, 2011. http://www.wpro.who.int/publications/docs/FORwebPDFFullVersionWIFS.pdf. Accessed 12 September 2013. 5 Office of the Registrar General and Census Commissioner India 2011. Census of India 2011: Provisional Population Totals, India series. New Delhi: Government of India, 2011. 6 World Health Organization. Physical status: the use and interpretation of anthropometry. Report WHO Expert Committee. WHO Tech Rep Series 1995; 854: 1-452. 7 Food and Agriculture Organization. Guidelines for measuring household and individual dietary diversity. Rome: FAO, 2011. http://www.fao.org/fileadmin/user_upload/wa_workshop/docs/FAO-guidelines-dietarydiversity2011.pdf. Accessed 2 September 2013. 8 World Health Organization. WHO anthroplus: software for assessing growth of the world’s children and adolescents. Geneva: World Health Organization, 2009. 9 United Nations Standing Committee on Nutrition. Adults: assessment of nutritional status in emergencyaffected populations. Geneva: SCN, 2000. 10 United Nations. Expert group meeting on youth development indicators. Indicators of poverty and hunger. New York: United Nations, 2005. 11 Landis RJ, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159-174. 12 Dasgupta A, Butt A, Saha TK, Basu G, Chattopadhyay A, and Mukherjee A. Assessment of Malnutrition Among Adolescents: Can BMI be Replaced by MUAC. Indian J Community Med. 2010 April; 35(2): 276–279. 13 Chakraborty R, Bose K, Koziel S. Use of mid-upper arm circumference in determining undernutrition and illness in rural adult Oraon men of Gumla District, Jharkhand, India. Rural and Remote Health 2011: 1754. Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 25 ©UNICEF India/Divakar Mani STATISTICAL TABLES Table 1 Sample population (column %) Characteristics Delhi Haryana Pooled Boys Girls Boys Girls Boys Girls TOTAL (N=1,063) (N=1,070) (N=917) (N=1,133) (N=1,980) (N=2,203) (N=4,183) Class 6-8 9-12 100 100 58.7 54.5 80.3 76.7 78.6 # # 41.3 45.5 19.7 23.3 21.4 Residence Rural 11.7 18.1 93.5 91.3 45.4 39.0 42.2 Urban 88.3 81.9 6.5 8.7 54.6 61.0 57.8 Adolescent characteristics Distance between school and home Mean (SD) 1.9 (1.4) 1.8 (1.5) 1.5 (1.7) 1.5 (1.5) 1.7 (1.6) 1.6 (1.5) 1.6 (1.5) <1 km 10.8 9.8 30.4 27.7 19.9 19.0 19.5 1-2 km 80.0 81.5 62.3 65.2 71.8 73.1 72.4 3 km or more 9.2 8.7 7.3 7.1 8.3 7.9 8.1 Children walking to school 81.7 80.9 89.4 93.5 85.3 87.4 86.4 Children working (n=88) 0.8 1.1 3.7 2.9 2.1 2.0 2.0 Paid work 33.3 33.3 38.2 36.4 34.9 37.8 36.5 Unpaid work 77.7 77.7 61.8 63.6 65.1 62.2 63.5 - 31.1 - 49.9 - 40.8 40.8 Sanitary napkins - 95.5 - 63.6 - 76.2 76.2 Free from school - 85.0 - - - 32.7 32.7 Purchased - 10.5 - 63.6 - 43.5 43.5 Cloth - 36.4 - 23.8 23.8 Illiterate 45.7 43.0 55.2 51.4 50.4 47.4 48.9 Primary 13.7 15.5 22.0 18.2 17.5 16.9 17.2 Middle or higher 40.6 41.5 22.8 30.4 32.1 35.7 33.9 Unemployed 79.2 77.0 78.0 77.8 78.8 75.7 77.3 Unskilled work 10.4 12.2 11.1 11.3 10.8 13.4 12.1 10.4 10.8 10.9 10.9 10.4 10.9 10.6 Menses among girls Started Material used during menses (n=932) 4.5 Parental characteristics Mother’s education Mother’s occupation1 Skilled work 28 Statistical tables Table 1 (cont.) Characteristics Delhi Haryana Pooled Boys Girls Boys Girls Boys Girls TOTAL (N=1,063) (N=1,070) (N=917) (N=1,133) (N=1,980) (N=2,203) (N=4,183) Parental characteristics Father’s education Illiterate 26.3 28.9 30.7 28.2 28.4 28.6 28.5 Primary 13.0 11.7 16.9 14.3 14.8 13.0 13.9 Middle or higher 60.7 59.4 52.4 57.5 56.8 58.4 57.6 Unemployed 6.1 9.8 10.4 9.6 7.9 9.6 8.8 Unskilled work 34.1 33.1 42.6 39.0 38.0 36.1 37.0 Skilled work 59.8 57.1 47.7 51.4 54.1 60.4 57.2 Kaccha 9.0 7.1 34.5 30.3 20.8 19.0 19.9 Pucca 89.8 91.7 64.1 68.7 77.9 79.9 78.9 Semi-pucca 1.1 1.2 1.4 1.0 1.3 1.1 1.2 Father’s occupation1 Housing Housing 2 Adolescents of Class 9-12 were not receiving WIFS tablets in Delhi. # Derived from Kuppuswamy’s classification for occupation. Houses made from mud, thatch, or other low quality materials are called kaccha houses, houses that use partly low quality and partly high quality materials are called semi-pucca houses, and houses made with high quality materials throughout, including the floor, roof and exterior walls, are called pucca houses. 1 2 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 29 Table 2 Multidimensional index of poverty1 (column %) Household characteristics Delhi Haryana Pooled Boys Girls Boys Girls Boys Girls TOTAL (N=1,063) (N=1,070) (N=917) (N=1,133) (N=1,980) (N=2,203) (N=4,183) BMI-for-age z-score <-2SD 29.2 19.1 31.4 26.1 30.2 22.7 26.4 Non-improved drinking water facility2 30.6 28.2 24.7 19.0 27.8 23.5 25.7 No toilet facility at home 15.8 14.4 29.6 22.9 22.2 18.8 20.5 No access to health facility 0.0 0.0 0.0 0.0 0.0 0.0 0.0 ≥3 people residing in one room 77.3 80.5 70.9 74.0 74.3 77.2 75.8 Illiteracy among adolescents 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Radio 13.9 16.4 10.8 13.9 12.5 15.1 13.8 Television 95.8 98.2 73.3 76.9 85.3 85.6 85.5 Mobile 97.7 97.9 90.8 91.4 94.5 94.1 94.3 Newspaper 17.4 17.1 11.9 13.2 14.9 15.1 15.0 Computer 5.3 6.1 0.9 2.3 3.1 4.2 3.7 Non-poor (0-1) 12.0 11.3 12.5 13.4 12.3 12.4 12.4 Moderate (2-3) 73.9 77.2 72.3 76.3 73.1 76.7 74.9 Severe (4-7) 14.1 11.5 15.2 10.3 14.6 10.9 12.8 Exposure to media Multidimensional index of poverty Includes seven components – BMI-for-age z-score <-2SD, drinking water facility, toilet facility at home, access to health facility, illiteracy or less than primary literacy among adolescents, ≥3 household members living in one room and exposure to media (newspapers, radio, television, computers or mobiles at home). Poverty threshold score of 2-3 indicates moderate poverty and 4-7 indicates severe poverty. 2 Non-improved drinking water facility included unprotected dug well, unprotected spring, tanker truck/cart with small tank and surface water. 1 30 Statistical tables Table 3 Anthropometry and dietary status of sample population (column %) Characteristics Delhi Haryana Pooled Boys Girls Boys Girls Boys Girls TOTAL (N=1,063) (N=1,070) (N=917) (N=1,133) (N=1,980) (N=2,203) (N=4,183) BMI-for-age z-score Thin <-2SD1 29.2 19.1 31.4 26.1 30.2 22.7 26.5 Severely thin <-3SD 10.2 5.5 8.6 6.2 9.4 5.8 7.6 Over nourished >2SD 0.9 1.1 0.0 0.3 0.5 0.6 0.6 65.8 74.8 67.4 72.2 66.5 73.4 70.0 Moderately thin 41.7 34.1 32.1 30.1 37.3 32.0 34.7 Severely thin2 <16 cm 9.0 6.3 7.2 6.6 8.2 6.4 7.3 25.3 31.1 23.4 22.0 24.4 26.4 25.4 Severely stunted <-3SD 7.1 9.7 4.7 3.9 6.0 6.5 6.3 9.5 22.9 17.8 23.1 13.3 23.0 18.2 Pulses or beans 90.5 90.5 69.3 66.1 80.7 77.9 79.3 Dark GLVs 56.4 50.6 28.8 28.9 43.6 39.4 41.5 Vitamin C rich fruit 39.2 40.4 21.4 23.5 31.0 31.7 31.3 Eggs 23.7 19.7 3.5 0.5 14.3 9.9 12.1 Fish/chicken/ meat 15.5 12.9 0.4 0.4 8.5 6.5 7.5 <3 food groups 46.1 47.7 48.2 51.6 47.1 49.8 48.5 3-5 food groups 53.6 51.6 51.8 48.4 52.8 49.9 51.4 6-9 food groups 0.3 0.7 - - 0.1 0.3 0.2 Normal ≤2SD & ≥-2SD MUAC Height-for-age z-score Stunted <-2SD1 Ate nothing before coming to school on survey day Iron-rich food consumed twice weekly Dietary diversity3 Includes children who are below -3SD from the WHO international growth standard median. Includes children who have values below 18.5 cm. 3 Nine food groups include consumption of cereals, dark green leafy vegetables (GLVs), vitamin A rich foods, fruits, organ meats, meats, eggs, pulses and milk in past 24-hour recall. 1 2 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 31 Table 4 Distribution of the sample population by age and sex (row %) Agewise distribution (completed years) BMI-for-age Height-for-age z-score z-score N <-2SD <-3SD <-2SD <-3SD MUAC <18.5 cm <16 cm 10 Boys 131 19.1 5.3 9.2 0.8 66.4 18.3 Girls 195 17.4 4.6 20.5 4.6 61.5 11.8 Boys 393 24.4 5.3 15.8 5.3 53.7 Girls 455 25.9 7.2 28.4 7.3 52.7 10.5 Boys 473 29.8 9.9 25.5 9.9 44.0 8.7 Girls 447 25.3 5.4 29.1 5.4 34.9 6.5 Boys 423 32.6 11.6 30.0 11.6 33.3 7.8 Girls 400 23.5 6.0 26.5 6.0 24.7 4.5 Boys 239 35.6 11.7 31.0 11.7 23.8 7.5 Girls 251 18.7 4.8 31.9 4.8 16.7 3.2 Boys 147 40.1 12.2 29.3 12.2 13.6 4.8 Girls 172 18.0 4.1 19.8 4.1 10.5 3.5 Boys 89 30.3 6.7 25.8 6.7 7.9 2.2 Girls 143 23.1 8.4 21.0 8.4 11.2 3.5 Boys 48 33.3 14.6 25.0 14.6 10.4 4.2 Girls 85 23.5 5.9 23.5 5.9 11.8 2.4 Boys 37 32.4 10.8 32.4 5.4 5.4 2.7 Girls 55 18.2 5.5 23.6 - 9.1 5.5 Boys 1,980 30.2 9.4 24.8 8.9 28.7 7.2 Girls 2,203 22.7 5.8 24.9 6.5 25.9 6.4 TOTAL 4,183 26.5 7.6 24.9 7.7 27.3 6.8 11 8.7 12 13 14 15 16 17 18-19 10-19 32 Statistical tables Table 5 Diagnostic accuracy of MUAC in identifying thinness BMI method (Gold standard) BMI <-2SD Undernourished BMI ≥-2 SD Non-undernourished Total MUAC method Prevalence Sensitivity = 26.2% = 73.4% Specificity = 79.2% Positive (<18.5 cm) Undernourished 803 (True +ve) 641(False +ve) 1444 PV+ PV- = 55.6% = 89.4% Negative (≥18.5 cm) Non-undernourished 296 (False –ve) 2443 (True –ve) 2739 LR+ LR- = 3.53 = 0.34 (95% CI 0.31-0.38) Total 1099 3084 BMI <-3SD Undernourished BMI ≥-3 SD Non-undernourished Total Prevalence Sensitivity = 7.6% = 62.6% Specificity = 97.3% MUAC method Positive (<16 cm) Undernourished 198 (True +ve) 106 (False +ve) 304 PV+ PV- = 63.2% = 97% Negative (≥16 cm) Non-undernourished 118 (False –ve) 3761 (True –ve) 3879 LR+ LR- = 33.9 = 0.38 (95% CI 0.31-0.38) Total 316 3867 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 33 Table 6 Consumption pattern of IFA in sample population of last three weeks from date of study (column %) Characteristics Delhi Haryana Pooled Boys Girls Boys Girls Boys Girls TOTAL (N=1,063) (N=1,070) (N=917) (N=1,133) (N=1,980) (N=2,203) (N=4,183) 91.1 92.5 90.8 86.8 90.9 89.6 90.3 Never (0) 8.9 7.5 9.2 13.2 9.0 10.4 9.7 Once 24.9 17.9 20.5 26.0 22.9 22.1 22.5 Twice 32.1 30.7 21.3 17.7 27.1 24.1 25.6 All three times 34.1 43.9 49.0 43.1 41.0 43.4 42.2 Supervised IFA consumption 43.8 50.4 69.8 65.4 44.1 41.9 43.0 NHE session in past 2 weeks 23.5 30.2 34.9 37.8 28.8 34.1 31.5 Albendazole consumption 65.2 65.5 63.4 62.3 64.4 63.9 64.2 IFA consumed at least once IFA Consumption Protocol followed* N=488 N=637 N=502 N=554 N=990 N=1,191 N=2,181 Empty stomach 1.2 0.6 6.8 3.6 4.0 2.0 3.0 Without water 0.8 0.6 3.0 0.7 1.9 0.7 1.3 Chewed 3.5 2.5 8.4 8.3 6.5 5.2 5.8 * last consumption NHE = nutrition and health education 34 Statistical tables Table 7 Undesirable effects faced by sample population in past three weeks from the date of study Characteristics Delhi (N=2,133) Haryana (N=2,050) Pooled (N=4,183) n % n % n % 1828 85.7 1740 84.9 3568 85.3 Faced 378 20.7 529 30.4 907 25.4 IFA discontinued 161 42.6 249 47.0 410 45.2 IFA continued 217 57.4 280 53.0 497 54.8 1450 79.3 1211 69.6 2661 74.6 435 30.0 259 21.4 694 26.1 1015 70.0 952 78.6 1967 73.9 1337 62.7 1293 63.1 2630 62.9 66 4.9 129 10.0 195 7.4 Week 1 (First consumption) IFA consumption Undesirable effects No undesirable effects Not faced IFA discontinued IFA continued Week 2 IFA consumption Undesirable effects Faced IFA discontinued 29 43.9 51 39.5 80 41.0 IFA continued 37 56.1 78 60.5 115 59.0 1271 95.1 1164 90.0 2435 92.6 IFA discontinued 410 32.2 271 23.3 685 28.1 IFA continued 861 67.8 893 76.7 1750 71.9 1125 52.7 1054 51.4 2181 52.1 No undesirable effects Not faced Week 3 (Recent consumption) IFA consumption Undesirable effects Faced Not faced 44 3.9 65 3.2 109 5.0 1081 96.1 989 96.8 2072 95.0 Details of undesirable effects1 Delhi (N=425) Pattern Faced once Haryana (N=625) Pooled (N=1,050) 380 89.4 548 87.7 928 88.4 Faced twice 28 6.6 57 9.1 85 8.1 Faced on every consumption 17 4.0 20 3.2 37 3.5 Nausea 40 9.4 60 9.6 100 9.5 Dizziness 38 8.9 42 6.7 80 7.6 340 80.0 498 79.7 838 79.8 Type Abdominal pain Black stool 3 0.7 11 1.8 14 1.3 Allergy 3 0.7 10 1.6 13 1.2 8 1.8 16 2.6 24 2.3 16 3.8 72 11.5 88 8.4 158 37.2 226 36.2 384 36.6 19 4.5 44 7.0 63 6.0 9 2.1 12 1.9 21 2.0 16 3.8 4 0.6 20 1.9 Fever Perceived causes 2 IFA eaten on empty stomach Body takes time to adjust to IFA Chewed/broken IFA IFA taken without water Consumed IFA during menses 1 2 Based on having undesirable effects at least once. Multiple choice question. Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 35 Table 8 Characteristics of adolescents who consumed one or two IFA vs those who consumed three IFA (N=3,775) Independent variables Compliance (column %) Consumed 1 or 2 IFA Consumed 3 IFA (N=2,006) (N=1,769) P value Adj. OR 95% CI1 Background characteristics of adolescents State Delhi 56.2 47.0 0.001 1.00 Haryana 43.8 53.0 Boys 49.3 45.9 0.037 Girls 50.7 54.1 1.1 [0.9,1.3] 6-8 78.3 77.2 0.419 - 9-12 21.7 22.8 Urban 52.2 43.1 0.001 Rural 47.8 59.9 0 68.9 75.9 0.001 1 28.9 19.6 0.3 [0.2,0.4] 2 2.2 4.5 0.4 [0.3,0.6] Negative/none 37.4 22.0 0.001 1.00 Positive 62.6 78.0 Negative 26.6 38.8 0.001 Positive 73.4 61.2 Negative 40.6 28.4 0.001 Positive 59.4 71.6 Low 21.7 33.1 0.001 High 78.3 66.9 1.4 [1.1,1.7]** Gender 1.00 Class Residence 1.00 1.1 [0.9,1.4] Undesirable effects No. of times faced 1.00 Enabling environment Parental pressure 1.9 [1.7, 2.3]*** Teachers’ pressure 1.00 1.7 [1.4,1.9]*** Peer pressure 1.00 1.4 [1.2,1.7]*** Self-efficacy 1 36 1.4[1.3,1.8]*** Adjusted for: state, gender, class, residence, number of times facing side effects, enabling environment – parents, school teachers, friends, self-motivated. OR (CI) = Odds Ratio (Confidence Interval) Significant at **p<0.01 and ***p<0.001 Statistical tables 1.00 Table 9 Compliance, barriers and perceived benefits for consumption of IFA1 (column %) Responses Delhi Haryana Pooled Boys Girls Boys Girls Boys Girls (N=703) (N=798) (N=645) (N=689) (N=1,348) (N=1,487) Reasons for compliance2 Positive influencers Friends 18.6 20.0 35.5 36.4 26.6 27.5 Family 28.6 20.1 35.6 50.6 38.5 44.3 Teachers 38.5 28.8 62.4 62.3 49.7 48.2 Media 0.3 0.2 0.2 0.1 0.2 0.2 Self-motivated 59.1 59 75.3 70.9 48.5 64.5 Did not face undesirable effect 15.2 24.8 13.1 12.2 22.8 19.7 Following school norms 33.9 31.7 22.9 30.7 28.7 31.2 Perceived benefits Felt healthier 35.7 34.6 23.4 19.7 29.8 27.7 Felt energetic 24.5 20.8 11.6 10.3 18.3 15.9 Better physical capacity 3.7 2.7 1.4 1.0 5.1 2.0 Less pain during menses - 4.4 - 2.9 - 3.7 Do not fall sick 18.6 17.7 20.0 17.1 37.7 17.4 Increased blood 1.3 1.3 9.5 5.5 5.2 3.2 No benefit 25.5 27.9 22.6 25.7 24.1 26.9 N=488 N=637 N=502 N=554 News 2.3 1.6 5.4 6.9 3.8 4.0 Parents 4.9 9.9 22.7 33.8 13.9 21.0 Barriers for nonconsumption3 N=990 N=1,191 Negative influencers School 1.6 2.8 11.6 13.2 6.7 7.6 Fell sick after consuming IFA previously 5.3 10.8 15.0 24.4 11.0 17.1 Fear consumption 6.6 9.4 19.9 27.8 13.3 18.0 IFA not available at school 8.4 3.8 7.4 9.9 7.9 6.6 Suffering from long term illness 3.5 1.6 0.6 0.7 2.0 1.2 Multiple answers. The total may not correspond to 100%. Consuming IFA tablet at least twice out of three times was considered as compliance (n=2,835). 3 Consuming IFA tablet fewer than two times out of three was considered for barriers (n=2,181). 1 2 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 37 Table 10 Sample and household characteristics of adolescents facing undesirable effects once or twice or more times vs. those who did not (N=3,775) Independent variables Undesirable effects (column %) None Once Two or more (N=2,725) (N=926) times (N=124) Delhi 78.3 19.4 2.3 Haryana 65.6 30.1 4.3 P value State 0.001 Gender Boys 50.9 40.4 31.5 Girls 49.1 59.6 68.5 6-8 80.4 72.8 58.1 9-12 19.6 27.2 41.9 2.0 2.4 31.5 98.0 97.6 68.5 Yes 85.9 87.5 86.3 No 14.1 12.5 13.7 <-2SD 26.4 27.2 22.6 >=-2SD 73.6 72.8 77.4 <-2SD 26.1 24.8 25.0 >=-2SD 73.9 75.2 75.0 Non-poor (0-1) 12.6 11.3 11.3 Moderate (2-3) 75.3 73.5 74.2 Severe (4-7) 12.1 15.1 14.5 0.001 Class 0.001 Work status Working Not working 0.786 Child walk to school 0.505 BMI-for-age z-score 0.539 Height-for-age z-score 0.752 Poverty index 38 Statistical tables 0.171 Table 11 Protocol for IFA administration and enabling environment for consumption of adolescents facing undesirable effects once or twice or more times vs. those who did not (N=3,775) Independent variables Undesirable effects (column %) None Once Two or more (N=2,725) (N=926) times (N=124) 100.0 13.2 15.3 Without water 0.0 86.8 84.7 Chewed 0.0 89.2 71.8 P value Protocols for IFA administration With water Swallowed 100.0 10.8 28.2 Empty stomach 100.0 83.9 90.3 0.0 15.0 9.7 Yes 85.2 78.3 79.8 No 16.8 21.7 20.2 Positive 77.6 50.0 46.0 Negative 22.4 50.0 54.0 Full stomach 0.001 0.001 0.001 Skip meal before school 0.003 Enabling environment Parental pressure 0.001 Teachers’ pressure Positive 69.2 63.5 63.7 Negative 30.8 36.5 36.3 Positive 70.1 52.3 51.6 Negative 29.9 47.7 48.4 High 13.3 36.3 37.1 Low 86.7 63.7 62.9 0.003 Peer pressure 0.001 Self-efficacy 0.001 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 39 Table 12 Association from stepwise multinomial logistic regression between adolescents and household characteristics, enabling environment and protocols for IFA consumption, controlling for all covariates Independent variables Delhi Faced undesirable effects once Faced undesirable effects at least twice OR 95% CI OR 95% CI 1.87*** [1.5,2.4] 2.77** [1.5,5.3] 0.97 [0.7,1.3] 0.80 [0.4,1.7] 1.30 [1.0,1.8] 1.15 [0.5,2.4] 1.30 [0.8,1.6] 1.40 [0.6,3.5] Moderate vs rich 0.907 [0.6,1.3] 1.668 [0.5,5.6] Severe vs rich 1.289 [0.8,2.0] 4.90* [1.3,18.9] 0.984 [0.8,1.3] 2.73*** [1.5,5.0] 3.477*** [2.7,4.5] 5.084*** [2.7,9.5] 1.296* [1.0,1.7] 2.576** [1.4,4.7] 0.655** [0.2,0.5] 0.745 [0.4,1.4] 0.318*** [0.9,1.5] 2.402** [1.3,4.3] 11.18** [2.0,63.6] 3.524*** [1.5,8.4] 10.97* [1.7,71.0] Gender Girls vs boys Class 6-8 vs 9-12 BMI-for-age <-2 vs ≥2SD No eating before coming to school Yes vs no Residence Urban vs rural Poverty Maternal literacy Illiterate vs literate Parental pressure No vs yes Teachers’ pressure No vs yes Positive peer pressure Yes vs no Self-efficacy Low/middle vs high Tablet consumed without water Yes vs no Tablet chewed Yes vs no Tablet consumed empty stomach Yes vs no State Haryana vs Delhi Observations 1,958 Significant at *p<0.1, **p<0.01 and ***p<0.001 40 Statistical tables 425 Haryana Pooled Faced undesirable effects once Faced undesirable effects at least twice Faced undesirable effects once Faced undesirable effects at least twice OR 95% CI OR 95% CI OR 95% CI OR 95% CI 1.357** [1.1,1.7] 1.935** [1.2,3.2] 1.53*** [1.3,1.8] 2.218*** [1.5,3.3] 1.328* [1.1,1.7] 2.310** [1.4,3.9] 1.158 [0.9,1.4] 2.283*** [1.4,3.6] 0.706** [0.6,0.9] 1.048 [0.6,1.9] 0.94 [0.8,1.5] 0.74 [0.5,2.0] 1.191 [0.9,1.5] 0.94 [0.5,1.7] 1.251* [1.0,1.5] 1.008 [0.6,1.6] 1.39 [1.0,2.0] 2.49** [0.5,1.7] 1.27 [1.0,1.6] 1.97* [1.1,3.5] 1.223 [0.9,1.7] 1.097 [0.6,2.2] 1.086 [0.9,1.4] 1.192 [0.7,2.1] 1.505 [1.0,2.3] 0.675 [0.2,2.0] 1.449* [1.1,1.6] 1.773 [0.8,3.7] 0.906 [0.7,1.1] 1.106 [0.7,1.8] 0.95 [0.8,1.1] 1.618* [1.1,2.4] 2.344*** [1.9,2.9] 2.567*** [1.6,4.2] 2.759*** [2.3,3.3] 3.439*** [2.3,5.1] 1.313* [1.1,1.6] 0.816 [0.5,1.4] 1.327*** [1.1,1.6] 1.297 [0.9,1.9] 0.682*** [0.5,0.9] 0.667 [0.4,1.1] 0.683*** [0.6,0.8] 0.696 [0.5,1.0] 1.302* [1.1,1.6] 0.929 [0.6,1.5] 0.488*** [0.4,0.6] 0.955 [0.6,1.44] 22.42** [2.2,230.4] 16.44** [4.1,66.5] 4.033*** [2.2,7.3] 4.033*** [2.3, 5.95] 50.27** [4.4,578.8] 50.27** [5.9,115.8] 2.396** [1.3,4.5] 2.043*** 1,817 625 3,775 [1.6,2.6] 1,050 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 41 Table 13 Responses of teachers to the information requested regarding WIFS programme in selected schools (column %) Responses Delhi Haryana Pooled (N=22) (N=27) (N=49) 0 4.5 55.6 32.7 1 86.4 40.7 61.2 2 9.1 3.7 6.1 Number of trainings received Nodal person for WIFS Teachers 90.9 85.2 87.8 Health service providers 9.1 0.0 4.1 Students (class monitor) 0.0 14.8 8.2 Kamzor bachon mein hotein hai (“It happens to children who are visibly undernourished”) 59.1 14.8 34.7 Sarkar ki dwai kharab hoti hai (“Government supply is of bad quality”) 40.9 85.2 65.3 Regular NHE to children, parents and leaders 9.1 14.8 10.2 Decrease IFA dosage 9.1 22.2 14.3 27.2 7.4 16.3 54.6 55.6 59.2 Reasons for undesirable effects Recommendations to address undesirable effects Others 1 None Others include: Follow WIFS protocol, to be given in presence of the emergency response system team. 1 NHE = nutrition and health education 42 Statistical tables Table 14 Responses of medical officers to the queries on IFA supply and protocol for administration (column %) Responses Delhi Haryana Pooled (N=13) (N=16) (N=29) Domino effect 30.8 37.5 38.2 Parents and community leaders do not allow distribution of IFA 23.1 12.5 17.2 23.1 18.8 20.7 Kuposhit aur anemic bachon ko hot hai (“It happens to children who are undernourished or anaemic”) 76.9 56.3 58.6 Children do not follow WIFS protocol2 54.3 84.2 62.1 Ek doosre ko dekh kar bimar hjatein hain (“Domino effect”) 69.2 31.3 48.3 Regular NHE to children, parents and local leaders 30.8 73.7 62.1 Collaboration with education department 46.2 43.8 44.8 Positive media publicity 23.1 12.5 17.2 0.0 12.5 6.9 Medicines3 at schools in case of emergency 61.5 68.8 65.5 Toll-free helpline number to schools 84.6 0.0 37.9 Contact details of hospitals/ERS team during emergency 84.6 50.0 65.5 Dedicated vehicle on the day of IFA administration 92.3 75.0 82.7 NHE to the school on management of undesirable effects 69.2 56.3 62.1 Perceived barriers in administration Teachers do not take responsibility Perceived reasons of undesirable effects 1 Recommendations to improve IFA administration1 Positive peer to peer counselling Components of ERS Multiple responses. Protocols: Swallow IFA tablet, take with 1 glass of water, consume after meal. 3 Medicines include paracetamol, citrizine, digene, Oral Rehydration Solution (ORS) and ciprofloxin. 1 2 ERS = emergency response system NHE = nutrition and health education Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 43 ©UNICEF India/Divakar Mani ANNEXES Annex 1 Population Proportionate to Size (PPS) methodology The sample population was selected using PPS cluster sampling method, which was as follows: 1. All the schools with a functional IFA supplementation programme under the Directorate of Education in Delhi and Haryana were enlisted. This information was obtained from the School Health Programme-MHFW. 2. Against the name of each school the corresponding population was written. 3. The cumulative population was calculated. For instance, in Delhi the cumulative population was 303,489. 4. The sampling interval was calculated using the formula: Total cumulative population ÷ 30 = 303,489÷30 = 101,16.3 ≅ 10,116 Therefore sampling interval is ≅ 10,116 5. A random number was selected using random number tables between 1 and 10,116. The random number selected was 9,899. 6. The school in which the cumulative population was nearly equal or greater to the random number (9,899) was selected as the first cluster. The first cluster was taken from school number 7. 7. Cluster No. 2: 9,899 (cluster No. 1) + sampling interval (10,116) = 20,015. A cluster having a cumulative population nearly equal to 20,015 was taken as the second cluster. The cluster was thus taken from school number 15. 8. The remaining 28 clusters were identified in a similar manner. 46 Annexes Annex 2 List of 30 clusters from Delhi selected for the study S No. District School Name Population Cluster No. 1. West A Khyala, No.2-SKV 1431 532 2. West A Hari Nagar, Block-L S(Co-ed)V 1408 539 3. West A Rajouri Garden Extn.-GBSSS 1462 548 4. West A Madipur, No.2-SKV 1303 557 5. West A Mansarovar Garden-SV 1467 565 6. West A Kirti Nagar-GGSSS 906 574 7. West A West Patel Nagar-SKV 2147 581 8. West B Nangloi, Kavita Colony-G(Co-ed)SSS 2469 586 9. West B Paschim Vihar, B 3-SKV 1172 593 10. West B Mundka Village-GBSSS 1684 599 11. West B Punjabi Basti-G(Co-ed)SSS 1771 605 12. West B Ambika Vihar-GGSSS 1922 610 13. West B Nangloi, J.J. Colony-GBSSS 3358 613 14. West B Vikas Puri, Block A-SBV 1919 622 15. West B Kakrola-SBV 2648 628 16. West B Kakrola-SKV 3212 635 17. West B Bindapur-GBSSS 1459 640 18. West B Mohan Garden-SKV 3552 644 19. West B GBSSS No.1, Mohan Garden 3056 649 20. West B Bindapur, Pocket-IV-G(Co-ed)SS 751 656 21. South West B Samalkha-GBSSS 2303 710 22. South West B Palam Village, No.2-SKV 1534 715 23. South West B Samalka-SKV 2258 720 24. South West B Dwarka, Sector II-G(Co-ed)SSS 2338 726 25. South West B Shahabad Mohammadpur-GBSSS 583 737 26. South West B Najafgarh-S(Co-ed)V 919 746 27. South West B Dhansa-SKV 447 765 28. South West B Malikpur-G(Co-ed)SSS 379 776 29. South West B Nangli Sakrawati Village-G(Co-ed)SS 794 786 30. South West B Najafgarh, Dharampura-GBSSS 1480 790 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 47 Annex 3 48 Annexes List of 30 clusters from Haryana selected for the study S No. District School Name Population Cluster No. 1. Hisar GGSSS, Adampur 1164 14 2. Hisar GSSSS, Kirtan 696 23 3. Hisar GSSS, Barwala 1677 58 4. Hisar GHS, Badhawar 579 75 5. Hisar GSSS, Nalwa 800 109 6. Hisar GHS, Bhaniamirpur 399 126 7. Hisar GHS, Mehjad 194 181 8. Hisar GHS, Sarangpur 292 213 9. Hisar GHS, Shekhpura 223 258 10. Hisar GMS, Puthimangal Khan 390 265 11. Hisar GSSS, Bhatol 288 276 12. Hisar GHS, Uklanamandi 2200 287 13. Jind GHS, Defence colony Jind urban 1400 319 14. Jind GSSS, Kharakramji 330 356 15. Jind GSSS, Pindara 250 360 16. Jind GGHS, Rajhana Kalan 156 403 17. Jind GSSS, Dhatrath 342 429 18. Jind GHS, Mohammad Kheri 234 430 19. Jind GMS, Ghagoria 350 492 20. Jind GMS, Amheri 440 511 21. Jind GMS, Ismailpur 67 534 22. Jind GMS, Koyal 168 567 23. Jind GSSS, Dumerkha Khurd 311 598 24. Jind GSSS, Uchana 235 611 25. Jind GHS, Loder 1587 622 26. Jhajar GSSS, Madana Kalan 249 662 27. Jhajar GSSS, Birohar 167 699 28. Jhajar GHS, Dehkora 151 745 29. Jhajar GSSS, Jasor Kheri 145 739 30. Jhajar GSSS, Dulhera 362 841 Annex 4 Sample size calculation Minimum sample size per district: Z 2 * (p) * (1-p) ______________________________ x 1.5 c2 ss = Sample size = 1.96 x 1.96 * (0.2) * (0.8) _______________________________ x 3 = 2049 0.03 x 0.03 Where: Z = 1.96 for 95% confidence interval p = 0.20 q = 0.80 c = 15% of 20 expressed as decimal = 0.03 Design effect = 3 Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 49 ACKNOWLEDGEMENTS Study design, data collection, analysis and writing Dr. Vani Sethi Ms. Palak Gupta Ms. Radhika Sood Nutrition Specialist, Child Development and Nutrition Programme, UNICEF India Country Office, Delhi PhD. scholar, Department of Foods and Nutrition, Lady Irwin College, University of Delhi, Delhi PhD. scholar, Department of Foods and Nutrition, Lady Irwin College, University of Delhi, Delhi Data collection Postgraduate students with specialization in ‘Foods and Nutrition’ from academic institutions in Delhi and Haryana: Lady Irwin College, Delhi Ms. Surbhi Aggarwal Ms. Prachi Ahuja Ms. Jagriti Jain Ms. Shaivya Rani Manav Rachna University, Haryana Ms. Surbhi Gandhi Ms. Tania Kar Ms. Shalini Khetarpal Ms. Mansi Rajput Ms. Shreya Ratra Ms. Rabia Saluja Ms. Himani Sharma Ms. Shivani Sharma Ms. Shalini Thakur Ms. Kavita Tiwari Ms. Khushboo Verma Ms. Kiran Yadav Statistical advice Dr. Dimple Kondal Public Health Foundation of India, New Delhi Study design and data collection facilitation Adolescent Health Division, Ministry of Health and Family Welfare, Government of India Dr. Sushma Dureja Joint Commissioner, Adolescent Health Dr. Sheetal Rahi Medical Officer, Adolescent Health Ms. Anshu Mohan Programme Manager, Adolescent Health 50 Contributors Department of Health and Family Welfare, Government of Haryana Dr. Inoshi Sharma Director, Adolescent Health Division Dr. Deepika Gupta Coordinator, School Health Scheme State Consultant, Adolescent Health Division Dr. Sadhna Agarwal District School Health Officer, Jind Dr. Anshu Dalal Senior Medical Officer, Jhajhar Dr. Kumud Sharma Civil Surgeon, Hissar Dr. AK Choudhary Department of Health and Family Welfare, Delhi Additional Director/Head, School Health Scheme Dr. JP Kapoor Coordinator, School Health Scheme Ms. Swati Singh District In-charge, South-West B Dr. BK Jha District In-charge, West B Dr. Poonam Kishore District In-charge, West A Dr. Sangeeta Rani UNICEF Dr. Jee Hyun Rah Nutrition Specialist, Child Development and Nutrition Programme, UNICEF India Country Office, Delhi Editor Ms. Delice Gan Funding UNICEF Design and pre-press production Lopez Design Incidence and Determinants of Undesirable Effects following Iron and Folic Acid Supplementation 51 NOTES 52 United Nations Children´s Fund India Country Office UNICEF House 73, Lodi Estate New Delhi 110003 Telephone: +91 11 24690401 www.unicef.in ©UNICEF India, 2014