Overview

This trial is active, not recruiting.

Conditions autoimmune diseases, systemic inflammatory process, knee pain chronic, osteoarthritis, rheumatoid arthritis
Treatments fish oil, vitamin d, placebo pill
Sponsor Brigham and Women's Hospital
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date January 2011
End date October 2017
Trial size 25876 participants
Trial identifier NCT01351805, R01 AR059086, R01AR059086

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
fish oil eicosapentaenoic acid (EPA)
Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
(Experimental)
Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
vitamin d cholecalciferol
Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
(Placebo Comparator)
Subjects will receive placebo pill.
placebo pill
placebo
(Experimental)
Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
fish oil eicosapentaenoic acid (EPA)
Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
vitamin d cholecalciferol
Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.

Primary Outcomes

Measure
Serum levels of Biomarkers of Systemic Inflammation
time frame: 5 years
Severity of Knee Pain
time frame: 5 years
Incident Autoimmune Diseases
time frame: 5 years

Secondary Outcomes

Measure
Interactions between the effects of vitamin D and those of fish oils for each of the primary outcomes
time frame: 5 years
Subgroup analysis of primary outcomes
time frame: 5 years

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Principal investigator Karen H Costenbader, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.