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VITAL Rhythm Study
Sponsor: Brigham and Women's Hospital
Summary
The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 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 individuals who do not have a prior history of these illnesses. The purpose of this ancillary study is to ascertain and adjudicate atrial fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or vitamin D supplementation influence atrial fibrillation risk in the general population. We also plan to examine how these agents might impact the development of AF subtypes (persistent versus paroxysmal), intermediate phenotypes for heart rhythm disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death and whether baseline blood levels and/or race modify treatment effects.
Official title: Vitamin D and Omega-3 Trial (VITAL Rhythm Study)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25119
Start Date
2012-10
Completion Date
2026-10
Last Updated
2025-10-07
Healthy Volunteers
Yes
Conditions
Interventions
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Fish oil placebo
Fish oil placebo
Vitamin D3 placebo
Vitamin D3 placebo
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States