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

Mass General Brigham

Status: Completed

Conditions: Osteoarthritis; Knee Pain Chronic; Rheumatoid Arthritis; Systemic Inflammatory Process; Autoimmune Diseases

Treatments: Dietary Supplement: Vitamin D; Other: placebo pill; Drug: Fish Oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01351805

R01AR059086 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 25,871 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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25,871 participants in 4 patient groups, including a placebo group

Fish Oil

Experimental group

Description:

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

Treatment:

Drug: Fish Oil

Other: placebo pill

Vitamin D

Experimental group

Description:

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

Treatment:

Other: placebo pill

Dietary Supplement: Vitamin D

placebo

Placebo Comparator group

Description:

Subjects will receive placebo pill.

Treatment:

Other: placebo pill

Vitamin D and Fish Oil

Experimental group

Description:

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

Treatment:

Drug: Fish Oil

Dietary Supplement: Vitamin D