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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 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 25,871 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01351805
The ClinicalTrials.gov registry entry for NCT01351805 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25,871 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vitamin D is the first listed.
NCT01351805 reports 0 study locations.
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.
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