Vitamin D + Fish Oil for Health Improvement
(VITAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Karen H Costenbader, MD, MPH
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for U.S. men and women without a history of cancer, heart disease, or stroke. It's focused on those with chronic knee pain due to conditions like rheumatoid arthritis and aims to see if vitamin D3 or fish oil supplements can help.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily dietary supplements of vitamin D3 or omega-3 fatty acids to assess effects on autoimmune disease, inflammation, and knee pain
Follow-up
Participants are monitored for safety and effectiveness after treatment, including annual questionnaires for knee pain and blood sample analysis for inflammation biomarkers
Extension
Observational follow-up for the development of new autoimmune diseases post trial closure
What Are the Treatments Tested in This Trial?
Interventions
- Fish Oil
- Placebo Pill
- Vitamin D
Vitamin D is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator