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

J Steroid Biochem Mol Biol. 2016 Jan;155(Pt B):252-6. doi: 10.1016/j.jsbmb.2015.04.006. Epub 2015 Apr 9.


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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiovascular Diseases / prevention & control*
  • Dietary Supplements*
  • Docosahexaenoic Acids / administration & dosage*
  • Double-Blind Method
  • Drug Combinations
  • Eicosapentaenoic Acid / administration & dosage*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / prevention & control*
  • Patient Selection
  • Research Report
  • United States
  • Vitamin D / administration & dosage*


  • Drug Combinations
  • Vitamin D
  • Docosahexaenoic Acids
  • Eicosapentaenoic Acid
  • Omacor

Associated data

  • ClinicalTrials.gov/NCT01169259