D-Health
Trial question
What is the role of vitamin D supplementation in older adults?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 21302
21302 patients (9777 female, 11525 male).
Inclusion criteria: adult participants aged 60-84 years.
Key exclusion criteria: self-reported hypercalcemia; hyperparathyroidism; kidney stones; osteomalacia; sarcoidosis; receipt of > 500 IU/day supplemental vitamin D; or unable to give consent because of language or cognitive impairment.
Interventions
N=10658 vitamin D (oral dose of 60,000 IU/month for 5 years).
N=10644 placebo (matching oral placebo for 5 years).
Primary outcome
Major cardiovascular event
6%
6.6%
6.6 %
4.9 %
3.3 %
1.6 %
0.0 %
Vitamin
D
Placebo
No significant
difference ↔
No significant difference in major cardiovascular event (6% vs. 6.6%; HR 0.91, 95% CI 0.81 to 1.01).
Secondary outcomes
Significant decrease in MI (1.8% vs. 2.2%; HR 0.81, 95% CI 0.67 to 0.98).
No significant difference in coronary revascularization (3.9% vs. 4.3%; HR 0.89, 95% CI 0.78 to 1.01).
No significant difference in stroke (1.6% vs. 1.6%; HR 0.99, 99% CI 0.8 to 1.23).
Conclusion
In adult participants aged 60-84 years, vitamin D was not superior to placebo with respect to major cardiovascular event.
Reference
Bridie Thompson, Mary Waterhouse, Dallas R English et al. Vitamin D supplementation and major cardiovascular events: D-Health randomised controlled trial. BMJ. 2023 Jun 28;381:e075230.
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