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

50 Years
Open (Enrolling by invite only)
Autoimmune Diseases, Systemic Inflammatory Process, Knee Pain Chronic, Osteoarthritis, Rheumatoid Arthritis

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Trial Information

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

Inclusion Criteria

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.

Type of Study:


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:


Principal Investigator

Karen H Costenbader, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:

R01 AR059086



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



Brigham and Women's Hospital Boston, Massachusetts  02115