Randomized controlled trial2019

Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, Gibson H, Gordon D, Copeland T, D'Agostino D, Friedenberg G, Ridge C, Bubes V, Giovannucci EL, Willett WC, Buring JE, VITAL Research Group

The New England journal of medicine · 1186 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 Heart, Lung, and Blood Institute
Government
National Institute of Mental Health
Government
National Cancer Institute
Government
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Government
NCI NIH HHS
Government
NIMH NIH HHS
Government
NHLBI NIH HHS
Government
NIAMS NIH HHS
Grants
National Institute of Mental Health (R01MH091448); National Cancer Institute (R01 CA138962); National Heart, Lung, and Blood Institute (U01 HL145386); National Cancer Institute (U01CA138962); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059086); National Heart, Lung, and Blood Institute (R01 CA138962)

Based on 8 listed funder(s).

Publication

Published
2018-11-10 · N Engl J Med · vol. 380 · issue 1 · pp. 33–44
Publisher
Massachusetts Medical Society
Cited
1642 citations · more than 100% of similar papers · 109.9× the field average
Impact
Top 10% most cited in its field
References
41 works
Access
Free to read
Research areas
Vitamin D Research Studies · Metabolism, Diabetes, and Cancer · Vitamin C and Antioxidants Research
Keywords
Medicine, Vitamin D and neurology, Disease, Cancer prevention, Cancer, Randomized controlled trial, Cardiovascular health, Vitamin, Internal medicine, Clinical trial
MeSH
humans, neoplasms, cardiovascular diseases, vitamins, vitamin d, treatment failure, incidence, follow-up studies, double-blind method, dietary supplements, aged, middle aged, female, male

16 authors

From US

  • JoAnn E. MansonBrigham and Women's Hospital; Harvard University
  • Nancy R. CookBrigham and Women's Hospital; Harvard University
  • I‐Min LeeBrigham and Women's Hospital; Harvard University
  • William ChristenBrigham and Women's Hospital; Harvard University
  • Shari S. BassukBrigham and Women's Hospital; Harvard University
  • Samia MoraBrigham and Women's Hospital; Harvard University

Abstract

Background

It is unclear whether supplementation with vitamin D reduces the risk of cancer or cardiovascular disease, and data from randomized trials are limited.

Methods

We conducted a nationwide, randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (cholecalciferol) at a dose of 2000 IU per day and marine n-3 (also called omega-3) fatty acids at a dose of 1 g per day for the prevention of cancer and cardiovascular disease among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were invasive cancer of any type and major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes). Secondary end points included site-specific cancers, death from cancer, and additional cardiovascular events. This article reports the results of the comparison of vitamin D with placebo.

Results

A total of 25,871 participants, including 5106 black participants, underwent randomization. Supplementation with vitamin D was not associated with a lower risk of either of the primary end points. During a median follow-up of 5.3 years, cancer was diagnosed in 1617 participants (793 in the vitamin D group and 824 in the placebo group; hazard ratio, 0.96; 95% confidence interval [CI], 0.88 to 1.06; P=0.47). A major cardiovascular event occurred in 805 participants (396 in the vitamin D group and 409 in the placebo group; hazard ratio, 0.97; 95% CI, 0.85 to 1.12; P=0.69). In the analyses of secondary end points, the hazard ratios were as follows: for death from cancer (341 deaths), 0.83 (95% CI, 0.67 to 1.02); for breast cancer, 1.02 (95% CI, 0.79 to 1.31); for prostate cancer, 0.88 (95% CI, 0.72 to 1.07); for colorectal cancer, 1.09 (95% CI, 0.73 to 1.62); for the expanded composite end point of major cardiovascular events plus coronary revascularization, 0.96 (95% CI, 0.86 to 1.08); for myocardial infarction, 0.96 (95% CI, 0.78 to 1.19); for stroke, 0.95 (95% CI, 0.76 to 1.20); and for death from cardiovascular causes, 1.11 (95% CI, 0.88 to 1.40). In the analysis of death from any cause (978 deaths), the hazard ratio was 0.99 (95% CI, 0.87 to 1.12). No excess risks of hypercalcemia or other adverse events were identified.

Conclusions

Supplementation with vitamin D did not result in a lower incidence of invasive cancer or cardiovascular events than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259 .).

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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