Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Serum levels of Biomarkers of Systemic Inflammation

Outcome Description:

Blood samples at baseline and in follow-up will be collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein, interleukin-6, and tumor necrosis factor-receptor 2. We will test whether either or both supplements are associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo).

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Karen H Costenbader, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

R01 AR059086

NCT ID:

NCT01351805

Start Date:

January 2011

Completion Date:

December 2016

Related Keywords:

• Autoimmune Diseases
• Systemic Inflammatory Process
• Knee Pain Chronic
• Osteoarthritis
• Rheumatoid Arthritis
• vitamin D
• omega-3 fatty acid
• fish oil
• prevention
• trial
• autoimmune disease
• rheumatoid arthritis
• psoriasis
• systemic inflammation
• Interleukin-6
• C-reactive peptide
• tumor necrosis factor
• osteoarthritis
• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Inflammation
• Osteoarthritis