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Randomized Controlled Trial
. 2012 Jan;33(1):159-71.
doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.

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

Joann E Manson  1 , Shari S Bassuk, I-Min Lee, Nancy R Cook, Michelle A Albert, David Gordon, Elaine Zaharris, Jean G Macfadyen, Eleanor Danielson, Jennifer Lin, Shumin M Zhang, Julie E Buring
Affiliations
Randomized Controlled Trial

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

Joann E Manson et al. Contemp Clin Trials. 2012 Jan.

Abstract

Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2 x 2 factorial trial of vitamin D (in the form of vitamin D(3) [cholecalciferol], 2000 IU/day) and marine omega-3 fatty acid (Omacor fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥ 50 and women aged ≥ 55. The mean treatment period will be 5 years. Baseline blood samples will be collected in at least 16,000 participants, with follow-up blood collection in about 6000 participants. Yearly follow-up questionnaires will assess treatment compliance (plasma biomarker measures will also assess compliance in a random sample of participants), use of non-study drugs or supplements, occurrence of endpoints, and cancer and vascular risk factors. Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment, and deaths will be ascertained through national registries and other sources. Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance; hypertension; cognitive decline; depression; osteoporosis and fracture; physical disability and falls; asthma and other respiratory diseases; infections; and rheumatoid arthritis, systemic lupus erythematosus, thyroid diseases, and other autoimmune disorders.

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Figures

Figure 1
Figure 1
Mechanisms by which vitamin D may lower cancer and cardiovascular risk. COX-2, cyclooxygenase-2; CRP, C-reactive protein; EFGR, epidermal growth factor receptor; IGF-1, insulin-like growth factor-1; IL-6, interleukin-6; IL-8, interleukin-8; IL-10, interleukin-10; MMP-9, matrix metalloproteinase-9; PG, prostaglandin; RAAS, renin-angiotensin-aldosterone system; TERT, telomerase reverse transcriptase; TGFß, transforming growth factor-ß; TNFα, tumor necrosis factor-α; VEGF, vascular endothelial growth factor.
Figure 2
Figure 2
Mechanisms by which marine omega-3 fatty acids may lower cancer and cardiovascular risk.
Figure 3
Figure 3
The VITamin D and OmegA-3 TriaL (VITAL) design.
See this image and copyright information in PMC

References

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