Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Status:
Active, not recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins