Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial
Scragg R, Stewart AW, Waayer D, Lawes CMM, Toop L, Sluyter J, Murphy J, Khaw KT, Camargo CA
JAMA cardiology · 379 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Independent funding
- Government
- National Institute for Health and Care Research
- Government
- Health Research Council of New Zealand
- Government
- Medical Research Council
- Government
- National Institute for Health Research (NIHR)
- Grants
- National Institute for Health and Care Research (NF-SI-0512-10114)
Based on 4 listed funder(s).
Publication
- Published
- 2017-04-06 · JAMA Cardiol · vol. 2 · issue 6 · p. 608
- Publisher
- American Medical Association
- Cited
- 493 citations · more than 100% of similar papers · 34.3× the field average
- Impact
- Top 10% most cited in its field
- References
- 47 works
- Access
- Free to read
- Research areas
- Vitamin D Research Studies · Nutrition, Genetics, and Disease · Vitamin C and Antioxidants Research
- Keywords
- Medicine, Placebo, Vitamin D and neurology, Population, Internal medicine, Myocardial infarction, Vitamin, Randomized controlled trial, Pediatrics
- MeSH
- humans, cardiovascular diseases, angina pectoris, myocardial infarction, arteriosclerosis, venous thrombosis, hypertension, vitamin d deficiency, cholecalciferol, vitamins, proportional hazards models, double-blind method, dietary supplements, aged, aged, 80 and over, middle aged, new zealand, female, male, arrhythmias, cardiac, heart failure, stroke
9 authors
From NZ, GB, US
- Robert K.R. Scragg · correspondingUniversity of Auckland
- Alistair W. StewartUniversity of Auckland
- Debbie WaayerUniversity of Auckland
- Carlene M.M. LawesUniversity of Auckland
- Les J ToopUniversity of Otago
- John SluyterUniversity of Auckland
Abstract
Importance
Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D.
Objective
To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population.
Design, setting, and participants
The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis.
Interventions
Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years).
Main outcomes and measures
The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis.
Results
Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes.
Conclusions and relevance
Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study.
Trial registration
clinicaltrials.gov Identifier: ACTRN12611000402943.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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