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
- Diseases
- Atrial fibrillation
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.