Department of International Health Newborn Vitamin A Supplementation and Early Infant Mortality: Current Evidence James Tielsch, Ph.D. Bangkok, March 2010 Newborn Vitamin A Supplementation Background • Vitamin A supplementation well accepted intervention for children 6 – 72 months of age. • Evidence for children <6 m, suggested no impact on child mortality. • Newborn period (first few days) may be different: • Almost all infants born with very low reserves. • Breastfeeding women often vitamin A deficient. • Trial in very preterm infants in US showed reduced rate of BPD. Randomized Trials in South and SE Asia Study Humphrey et al. (1996) Rahmathullah et al. (2003) Klemm et al. (2009) Country Design Indonesia Hospital-based individually randomized trial Community-based India individually randomized trial Presenter’s Name Date Bangladesh Study Size (Live Births) Vit. A: 1034 Control:1033 Age at Dosing Mean = 16.4hrs 88.2% within 24 hrs Vit. A: 5,786 Control: 5,833 Median = 26hrs 80% within 48 hrs Community-based cluster randomized trial Vit. A:7.953 Control: 7,984 Median = 7hrs 84% within 48 hrs Not completed ? Bhutta et al. (unfinished) Pakistan Community-base cluster randomized trial Vit. A: 180 clusters Cont.: 180 clusters ? (unfinished) India ? ? Randomized Trials in South and SE Asia Study Country Results Humphrey et al. (1996) Indonesia RR (IMR) =0.36 (0.16, 0.87) Rahmathullah et al. (2003) India RR (6m IMR) = 0.78 (0.63, 0.96) Presenter’s Name Date Klemm et al. (2009) Bangladesh RR (6m IMR) =0.85 (0.73, 1.00) POOLED India & Bangladesh RR = 0.83 (0.72-0.94) Pooled Results by Maternal Characteristics Presenter’s Name Date Pooled Results by Infant Characteristics Presenter’s Name Date Randomized Trials in Africa Two trials in Africa have shown no impact of newborn vitamin A supplementation on early infant mortality. • Zimbabwe (HIV neg infants) • No maternal vitamin A deficiency. • Very low mortality rates. • Guinea Bissau • Little vitamin A deficiency Presenter’s Name • Combined with BCG vaccination Date • Provided care for sick infants. • Other reasons ??? • Zambia trial just getting started. • ? SHOULD DATA BE COMBINED WITH ASIAN TRIALS ? Conclusions • Trials from Asia provide strong evidence that supplementation with 50,000 IU vitamin A within the first few days after birth reduces early infant mortality in south & southeast Asian settings. • Waiting until 2 or more weeks after birth will likely have little impact on mortality. • Newborn vitamin A supplementation is unlikely to have an Presenter’s Name impact in settings with little maternal vitamin A deficiency Date and where early infant mortality rates are already low. • Newborn vitamin A supplementation is a highly costeffective intervention that can assist countries in meeting MDG-4.