The effect of monthly vitamin D supplementation on fractures: a tertiary outcome from the population-based, double-blind, randomised, placebo-controlled D-Health trial
Authors' conclusion
These findings do not support concerns that bolus doses of vitamin D administered monthly increase fracture risk. Long-term supplementation might reduce the incidence of total fractures, but additional research is needed to clarify this effect.
Study context
- Population
- Adults aged 60–84 years living in Australia; 45.7% women, mean age 69.3 years (SD 5.5)20,326 analysed
- Participants
- 21,315 adults
- Comparison
- Monthly oral vitamin D3 60 000 international units (IU) vs placebo for up to 5 years
- Vitamin Dn = 10,154
- Placebon = 10,172reference
- Primary endpoint
- Total fractures (main outcome), ascertained through linkage with administrative datasets
- Follow-up
- Median 5.1 years (IQR 5.1-5.1)
Methodological detailspopulation-based, double-blind, placebo-controlled, tertiary outcome analysis, Participants without linked data excluded (989 [4.6%])
- Population-based
- Double-blind
- Placebo-controlled
- Tertiary outcome analysis
- Participants without linked data excluded (989 [4.6%])
Primary result
As reported in the abstract
Total fractures (≥1 fracture)
- No effect on fracture risk overall, HR
- 0.94 (0.84-1.06) (95% CI)
- Interaction between randomisation group and time not significant
- P = 0.14
Further findings
Non-vertebral fractures
- Overall HR
- 0.96 (0.85-1.08) (95% CI)
Major osteoporotic fractures (hip, wrist, proximal humerus, spine)
- Overall HR
- 1.00 (0.85-1.18) (95% CI)
Hip fractures
- Overall HR
- 1.11 (0.86-1.45) (95% CI)
Original publication
The effect of monthly vitamin D supplementation on fractures: a tertiary outcome from the population-based, double-blind, randomised, placebo-controlled D-Health trial. Lancet Diabetes Endocrinol. Published 31 March 2023. doi:10.
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