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Randomized Controlled Trial
. 2016 Jan;155(Pt B):252-6.
doi: 10.1016/j.jsbmb.2015.04.006. Epub 2015 Apr 9.

Update on the Vitamin D and OmegA-3 trial (VITAL)

Aruna D Pradhan  1 , JoAnn E Manson  2
Affiliations
Randomized Controlled Trial

Update on the Vitamin D and OmegA-3 trial (VITAL)

Aruna D Pradhan et al. J Steroid Biochem Mol Biol. 2016 Jan.

Abstract

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 2×2 factorial randomized, double-blind, placebo-controlled trial of the benefits and risks of vitamin D (vitamin D3 [cholecalciferol], 2000 IU/d) and marine omega-3 fatty acids (Omacor(®) 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.

Trial registration: ClinicalTrials.gov NCT01169259.

Keywords: Cancer; Cardiovascular disease; Cholecalciferol; Omega-3 fatty acids; Primary prevention; Randomized controlled trial; Vitamin D.

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Figures

Fig. 1
Fig. 1
Factorial design of the vitamin D and omega-3 trial.
See this image and copyright information in PMC

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