Journal
JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY
Volume 155, Issue -, Pages 252-256Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.jsbmb.2015.04.006
Keywords
Cancer; Cardiovascular disease; Cholecalciferol; Primary prevention; Omega-3 fatty acids; Vitamin D; Randomized controlled trial
Funding
- National Cancer Institute
- National Heart, Lung and Blood Institute, Office of Dietary Supplements
- National Institute of Neurological Disorders and Stroke
- National Center for Complementary and Alternative Medicine
- NIH
- [U01CA138962]
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Despite continued appreciation of the potential role of vitamin D and omega-3 fatty acids in the prevention of cancer and cardiovascular disease (CVD), there remain no completed large-scale, randomized trials of these agents for the primary prevention of cancer or CVD in a population that has not been selected on the basis of elevated risk. The VITamin D and OmegA-3 TriaL (VITAL) is a 2 x 2 factorial randomized, double-blind, placebo-controlled trial of the benefits and risks of vitamin D (vitamin D-3 [cholecalciferol], 2000 IU/d) and marine omega-3 fatty acids (Omacor (R) fish oil, a 1 g/d) in the primary prevention of cancer and CVD among 25,875 men and women, aged >= 50 and >= 55 years, respectively. Randomization began in November 2011 and was completed in March 2014. This report will describe the rationale for the trial and currently available randomized trial data, summarize related ongoing large-scale trials, and provide a brief overview of study design, and an update on randomization milestones, racial/ethnic diversity, biorepository activities, in-depth phenotyping of a subcohort, and ancillary studies. (C) 2015 Elsevier Ltd. All rights reserved.
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