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NCT02178410Active, not recruitingPhase 3

VITAL Rhythm Study

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
25119 (actual)
First submitted
25 Jun 2014
Start date
Oct 2012
Primary completion date
Oct 2026
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT02178410

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 25119
  • From Oct 2012 to the primary completion date, Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \- physician diagnosis of atrial fibrillation prior to randomization

Who the study is looking for

  • \- physician diagnosis of atrial fibrillation after randomization
  • and/or
  • \- cardiovascular death

Criteria the registry did not label

  • To be eligible this ancillary study participants must be enrolled in the Vitamin D and Omega-3 Trial (VITAL; National Clinical Trial (NCT) 01169259) and meet the following criteria:

Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.