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NCT02178410 · ClinicalTrials.gov registry record · Phase 3
VITAL Rhythm Study
A Phase 3 study of Cardiovascular Disease, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 3
- Development phase
- 25,119
- Enrollment target
- 1
- Study location
NCT02178410 is a Phase 3 study of Cardiovascular Disease that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 25,119 participants, above the 2,529-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (893% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02178410, a Phase 3 study of Cardiovascular Disease, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 25,119 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Vitamin D3
- DIETARY_SUPPLEMENT Vitamin D3 placebo
- DIETARY_SUPPLEMENT Fish oil placebo
- DRUG Omega-3 fatty acids (fish oil)
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25,119 participants |
| Start Date | 2012-10 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02178410
The ClinicalTrials.gov registry entry for NCT02178410 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 25,119 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,529-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (893% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 4 interventions - of which Vitamin D3 is the first listed.
NCT02178410 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02178410 about?
NCT02178410 is a clinical study titled "VITAL Rhythm Study". 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 stro...
What is the current status of trial NCT02178410?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 25,119 participants. The study started on 2012-10. Estimated completion is 2026-10.
What conditions does trial NCT02178410 study?
This clinical trial studies the following conditions: Cardiovascular Disease.
What interventions are being tested in trial NCT02178410?
The interventions under investigation include: Vitamin D3 (DIETARY_SUPPLEMENT), Vitamin D3 placebo (DIETARY_SUPPLEMENT), Fish oil placebo (DIETARY_SUPPLEMENT), Omega-3 fatty acids (fish oil) (DRUG).
Who is sponsoring clinical trial NCT02178410?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02178410 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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