Vitamin D + Fish Oil for Health Improvement (VITAL Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByKaren H Costenbader, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

Stay on your current meds

Approved in 3 jurisdictions

Trial Summary

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.

Eligibility Criteria

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

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. Trial enrollment complete

Participant Groups

The study tests whether daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of autoimmune diseases, lower inflammation markers, or alleviate chronic knee pain in participants.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin D and Fish OilExperimental Treatment2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group II: Vitamin DExperimental Treatment2 Interventions

Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.

Group III: Fish OilExperimental Treatment2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group IV: placeboPlacebo Group1 Intervention

Subjects will receive placebo pill.

Vitamin D is already approved in United States, European Union, Canada for the following indications: