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NCT01351805 · ClinicalTrials.gov registry record · NA
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 25,871
- Enrollment target
NCT01351805: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT01351805 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 25,871 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1744% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01351805, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 25,871 participants
- Enrollment target
Study Summary
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) 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. This ancillary study is being conducted among VITAL participants and will examine whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B) biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and in follow-up will be collected in a randomly selected subcohort of 1500 individuals and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein, interleukin-6, and tumor necrosis factor-receptor 2. Approximately 1300 individuals with chronic, frequent knee pain will be followed with annual questionnaires to evaluate the effects of the supplements on chronic knee pain.
Primary Outcome
In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whet
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DRUG Fish Oil
- OTHER placebo pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25,871 participants |
| Start Date | 2010-07 |
| Est. Completion | 2025-02 |
| Phase | NA |
What the finished NCT01351805 record still lists
NCT01351805 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 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1744% higher).
The record links to 0 conditions, and to 3 interventions - of which Vitamin D is the first listed.
NCT01351805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01351805 about?
NCT01351805 is a clinical study titled "Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain". The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) 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...
What is the current status of trial NCT01351805?
This trial is currently completed. It is a NA study. The enrollment target is 25,871 participants. The study started on 2010-07. Estimated completion is 2025-02.
What interventions are being tested in trial NCT01351805?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Fish Oil (DRUG), placebo pill (OTHER).
Who is sponsoring clinical trial NCT01351805?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01351805's enrollment target sits among peer trials
25,871 9th of 2000 higher than 1,992 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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