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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: Active Phase 3 study of Cardiovascular Disease, sponsored by Brigham and Women's Hospital.
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 2,514-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (899% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess whether omega-3 fatty acids (Omacor® 840 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) or vitamin D3 supplementation influences risk of atrial fibrillation in a general population of men and women without prior cardiovascular disease.
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 |
What the registry record for NCT02178410 still lists
NCT02178410 is an interventional study that assigns participants to a tested intervention. Its 25,119 participants enrollment target places it among the larger protocols in the corpus, above the 2,514-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (899% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cardiovascular Disease
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Where NCT02178410's enrollment target sits among peer trials
25,119 5th of 137 higher than 133 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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