Vitamin D supplements for fracture prevention in schoolchildren in Mongolia: analysis of secondary outcomes from a multicentre, double-blind, randomised, placebo-controlled trial
Primary result · One or more fracturesResult — go to the resultAdjusted relative risk 1.10 95% CI 0.93–1.29Authors' conclusion
Oral vitamin D supplementation at a dose of 14 000 IU/week for 3 years was safe, but did not influence fracture risk in schoolchildren living in Mongolia who had a high baseline prevalence of vitamin D deficiency.
Study context
- Population
- Schoolchildren aged 6–13 years with negative QFT, 18 public schools in Ulaanbaatar, Mongolia; median age 9.2 years, 95.5% with baseline serum 25(OH)D <50 nmol/L8,348 analysed
- Participants
- 8,851 participants
- Comparison
- Weekly oral vitamin D3 vs placebo for 3 years
- Vitamin Dn = 4,418
- Placebon = 4,433reference
- Primary endpoint
- Incidence of fractures (prespecified secondary outcome of the trial)
- Follow-up
- Median 3.0 years (IQR 2.9-3.1)
Methodological detailsmulticentre, double-blind, placebo-controlled, prespecified secondary outcomes
- Multicentre
- Double-blind
- Placebo-controlled
- Prespecified secondary outcomes
Primary result
One or more fractures · median follow-up 3.0 years
Adjusted relative risk
1.10
95% CI 0.93–1.29
P = 0.27
Events by treatment group
Vitamin Dvs Placebo
adjusted RR 1.10 (95% CI 0.93–1.29); P = 0.27
As reported in the abstract
Safety
- Incidence of adverse events did not differ between study groups
Original publication
Vitamin D supplements for fracture prevention in schoolchildren in Mongolia: analysis of secondary outcomes from a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. Published 1 December 2023. doi:10.
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