Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | October 2017 |
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in
25,876 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 2000 individuals and
analyzed for changes in biomarkers of systemic inflammation: C-reactive protein,
interleukin-6, and tumor necrosis factor-receptor 2. Approximately 2000 individuals with
chronic, frequent knee pain will be followed with annual questionnaires to evaluate the
effects of the supplements on chronic knee pain.
25,876 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 2000 individuals and
analyzed for changes in biomarkers of systemic inflammation: C-reactive protein,
interleukin-6, and tumor necrosis factor-receptor 2. Approximately 2000 individuals with
chronic, frequent knee pain will be followed with annual questionnaires to evaluate the
effects of the supplements on chronic knee pain.
As for the parent trial, VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259). Individuals
with chronic, frequent knee pain at study baseline will be followed as a subcohort.
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