Clinical Trials Directory

Trials / Completed

CompletedNCT01351805

Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25,871 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFish OilSubjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
DIETARY_SUPPLEMENTVitamin DSubjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
OTHERplacebo pillplacebo

Timeline

Start date
2010-07-01
Primary completion
2018-11-10
Completion
2025-02-01
First posted
2011-05-11
Last updated
2025-12-03
Results posted
2021-01-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01351805. Inclusion in this directory is not an endorsement.