Vitamin D and Omega-3 Trial

Vitamin D and Omega-3 Trial (VITAL) (VITamin D and OmegA-3 TriaL) is a "randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses".[1][2] Its estimated completion date is November 2018.[3]The study sponsor and investigators have responsibility for its safety and scientific validity. The Sponsor is Brigham and Women's Hospital with collaborators, 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 Integrative Health, Pharmavite LLC, Pronova BioPharma and BASF.[3]

It aims to enroll 20,000 participants (women 55 or over, men 50 or over)[4][5] who will be randomized to one of four groups:[2]

  • daily vitamin D (2000 IU) and fish oil (1 g);
  • daily vitamin D and fish-oil placebo;
  • daily vitamin-D placebo and fish oil;
  • daily vitamin-D placebo and fish-oil placebo.

Participants will answer annual questionnaires[2] to determine effects on risk of cancer, heart disease, stroke, osteoporosis, diabetes, memory loss and depression.[6]

References
  1. "Massive Vitamin-D/Omega-3 Trial for CVD, Cancer Prevention"
  2. VITAL Study
  3. Clinical trial number NCT01169259 for "Vitamin D and Omega-3 Trial (VITAL)" at ClinicalTrials.gov
  4. Manson, JE.; Bassuk, SS.; Lee, IM.; Cook, NR.; Albert, MA.; Gordon, D.; Zaharris, E.; Macfadyen, JG.; et al. (Jan 2012). "The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease". Contemp Clin Trials. 33 (1): 159–71. doi:10.1016/j.cct.2011.09.009. PMC 3253961. PMID 21986389.
  5. "Questions about the Vital Study". www.vitalstudy.org. Retrieved April 5, 2013.
  6. Manson, Joann E. "The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease". Contemp Clin Trials. 33 (1): 159–71.


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