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ACTIVE NOT RECRUITING
NCT02178410
PHASE3

VITAL Rhythm Study

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day.

DRUG

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 \[DHA\]).

DIETARY_SUPPLEMENT

Fish oil placebo

Fish oil placebo

DIETARY_SUPPLEMENT

Vitamin D3 placebo

Vitamin D3 placebo

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States