Vitamin D Supplementation in
Healthy Children and Adolescents
SCH Journal Club
Rachel Harrison
20th September 2012
Background
• Vit D plays an essential role in maintaining good health:
– calcium and phosphate regulation
– may regulate cell growth, neuromuscular and immune
function, and reduction of inflammation.
• Sunshine!
• Vitamin D supplementation agenda since 1990’s
• An independent advisory committee is reviewing current
recommendations on vit D (expected 2014)
Background
• Vitamin D deficiency serum 25(OH)D level ≤25nmol/l
• Insufficiency serum 25(OH)D level between 26 and
50nmol/l
DOH
• DOH says the following people may be at risk of vit D
deficiency:
– all pregnant and breastfeeding women
– all children aged under five years old
– all people aged 65 or over
– people who are not exposed to much sun
– people who have darker skin (because their bodies
are less able to produce as much vit D)
Current Guidelines
• http://www.sheffield.nhs.uk/professionals/resources/Vita
min_D_guidelines_children_Final_March%202012[1].pdf
• Advice – obtain Vit D from safe sun exposure and diet.
• Improving availability and uptake of Vit D supplements
for children in multiethnic populations is essential to the
strategy of rickets prevention.
• During treatment of deficiency consider referral to
secondary care at any stage if new symptoms cause
parental or professional concern.
Trust Policy
Available multivitamin preparations
Product
Vitamin D content
Dose
Other considerations
Healthy Start Drops
(10ml).
Multivitamin preparation
Colecalciferol – 300IU per 5
drops
300IU / dose (5 drops)
Free from soya and peanut
residues
Dalivit (25ml or 50ml
bottles).
Multivitamin preparation
Licensed product.
Ergocalciferol 400 IU per 0.6
mL
6 weeks- 1year –200IU 0.3ml (7drops) daily
≥ 1 year 400IU = 0.6ml = 14
drops daily
Can be added to squash, juice,
milk or jam for ease of
administration.
Does not contain peanut oil or
soya
Abidec (25ml)
Multivitamin preparation
Licensed product
Ergocalciferol 400 IU per 0.6
mL,
Birth -1year -200units –
0.3ml (7drops) daily
≥ 1 year 400iu = 0.6ml = 14
drops daily
Contains peanut oil.
Contraindicated in patients
with a peanut
allergy. Also avoid in
patients with a soya allergy.
Adcal D3 chewable
tablets / caplets
Contains calcium and
Vitamin D
Chewable tablets Colecalciferol 400IU
/tablet (and 600mg
Calcium)
Caplets –colecalciferol
200IU/caplet (and 300mg
Calcium)
Chewable tablets – One
daily (only licensed in
children above 12
years)
Caplets – Two daily (only
licensed in children
above 12 years)
Please note the difference
strengths between the
chewable tablets and the
caplets
Contains soya oil in the chewable
tablets. Refer to SPC for full
list of excipients.
The Clinical Question
Population
Healthy children and adolescents
Intervention
Vitamin D supplementation
Comparison
Placebo
Outcome
Bone Density
Study Design
Systematic Review
Effects of Vitamin D supplementation
on bone density in healthy children: a
systematic review
Winzenberg,T. Powell, S. Shaw, K A. Jones, G.
BMJ. 2011;342:c7254.
Objectives
• To determine effectiveness of Vitamin D
supplementation for improving BMD in children and
adolescents
• To determine if effects of supplementation vary with
factors such as vitamin D dose and status
Methods
• Systematic review and meta-analysis
• RCT’s of vitamin D supplementation including a placebo
control
• Children and adolescents aged 1 month to <20 years
• Identification of papers
– Databases
– Conference abstracts
– Cited references
Methods
•
•
•
•
•
Extracted data by 2 reviewers
Percent change in baseline of bone outcomes
Standardised mean difference
Hetrogeneity
Fixed effects model
Outcomes
• BMD – spine, radius, hip
• BMC – total body
• Subgroup analysis
–
–
–
–
–
Age
Gender
Pubertal stage
Vitamin D dose
Vitamin D status
Results – Papers Reviewed
1653 papers identified
1599 excluded
54 disagreements
6 German papers
23 full text review
4 not RCTs
3 children not 1/12 to <20 yr
2 not bone outcomes
1 not Vit D intervention
1 not placebo controlled
12 papers for 7 studies
1 no variance measured
reported
6 studies included in
meta analysis
Results – Baseline Characteristics
Event Title If Required (Change Text in Footer)
Results – Main Effects
Event Title If Required (Change Text in Footer)
Results – Forrest Plot
Event Title If Required (Change Text in Footer)
Results – Vit D Status
Are the results of the review valid?
• Did the review address a clearly focused question?
Yes – Clear population, intervention, and outcome
• Did the authors look for the appropriate sort of papers?
Yes – RCT’s placebo controlled
Is it worth continuing?
• Do you think the important, relevant studies were included?
Yes – appropriate databases searched, no language restrictions,
reference lists of cited studies searched, conference
abstracts
•
Did the review’s authors do enough to assess the quality of
the included studies?
Yes – independently assessed by 2 reviewers
•
If the results of the review have been combined, was it
reasonable to do so?
Yes – Similar studies, similar outcomes
What are the results?
• What are the overall results of the reviews?
LS BMD 0.15 (-0.01 to 0.31; p=0.07) standardised mean
difference
Supplementation not beneficial in children and adolescents
with normal Vit D levels
In deficient children may be useful, but needs confirmation
• How precise are the results?
Not sure – Confidence intervals reported, standardised
mean difference
Will the results help locally?
• Can the results be applied to the local population?
Yes - children 8-17 yrs
• Were all important outcomes considered?
Not sure – main outcome covered
• Are the benefits worth the harms and costs?
No
Summary and Conclusions
• Overall a good paper
• Publication of negative results
• Clear bottom line reported
• For clinicians and other health professionals:
No action to be take. What this space.