Vitamin D and Omega-3 Trial (VITAL Rhythm Study)

Who is this study for? Patients with atrial fibrillation and/or cardiovascular death
What treatments are being studied? Vitamin D3+Omega-3 fatty acids
Status: Unknown
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• physician diagnosis of atrial fibrillation after randomization

⁃ and/or

• cardiovascular death

Locations
United States
Massachusetts
Brigham and Women's Hospital
Boston
Time Frame
Start Date: 2012-10
Completion Date: 2024-01
Participants
Target number of participants: 25119
Treatments
Active_comparator: Vitamin D + fish oil
Active_comparator: Vitamin D + fish oil placebo
Active_comparator: Vitamin D placebo + fish oil
Placebo_comparator: Vitamin D placebo + fish oil placebo
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov