Vitamin D Supplementation in Healthy Children and Adolescents

SCH Journal Club

Rachel Harrison20th 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/Vitamin_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 preparationLicensed 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 Reviewed1653 papers identified

1599 excluded54 disagreements6 German papers

23 full text review

4 not RCTs3 children not 1/12 to <20 yr

2 not bone outcomes1 not Vit D intervention1 not placebo controlled

6 studies included in meta analysis

1 no variance measured reported12 papers for 7 studies

Results – Baseline Characteristics

Event Title If Required (Change Text in Footer)

Results – Main Effects

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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

differenceSupplementation not beneficial in children and adolescents

with normal Vit D levelsIn 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.