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NCT01169259 · ClinicalTrials.gov registry record · Phase 3
Vitamin D and Omega-3 Trial (VITAL)
A Phase 3 study of Cancer and Cardiovascular Disease, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 3
- Development phase
- 25,871
- Enrollment target
- 1
- Study location
NCT01169259: Active Phase 3 study of Cancer and Cardiovascular Disease, sponsored by Brigham and Women's Hospital.
NCT01169259 is a Phase 3 study of Cancer and Cardiovascular Disease that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 25,871 participants, above the 3,449-participant average among 615 other Cancer trials with a reported enrollment target (650% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169259, a Phase 3 study of Cancer and Cardiovascular Disease, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 25,871 participants
- Enrollment target
- 1
- Study location
Study Summary
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 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 people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
Primary Outcome
Number of participants with invasive cancer of any type
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 | 25,871 participants |
| Start Date | 2010-07 |
| Est. Completion | 2026-05 |
| Phase | Phase 3 |
What the registry record for NCT01169259 still lists
NCT01169259 is an interventional study that assigns participants to a tested intervention. Its 25,871 participants enrollment target places it among the larger protocols in the corpus, above the 3,449-participant average among 615 other Cancer trials with a reported enrollment target (650% higher).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which vitamin D3 is the first listed.
NCT01169259 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01169259 about?
NCT01169259 is a clinical study titled "Vitamin D and Omega-3 Trial (VITAL)". The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 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 peo...
What is the current status of trial NCT01169259?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 25,871 participants. The study started on 2010-07. Estimated completion is 2026-05.
What conditions does trial NCT01169259 study?
This clinical trial studies the following conditions: Cancer, Cardiovascular Disease.
What interventions are being tested in trial NCT01169259?
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 NCT01169259?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01169259 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 Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01169259's enrollment target sits among peer trials
25,871 14th of 615 higher than 602 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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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