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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25871 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Autoimmune Diseases Systemic Inflammatory Process Knee Pain Chronic Osteoarthritis Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fish Oil

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

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DRUG

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

placebo pill

Intervention Type OTHER

placebo

Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

placebo pill

Intervention Type OTHER

placebo

Subjects will receive placebo pill.

Group Type PLACEBO_COMPARATOR

placebo pill

Intervention Type OTHER

placebo

Vitamin D and Fish Oil

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

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DRUG

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

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fish Oil

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

Intervention Type DRUG

Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

placebo pill

placebo

Intervention Type OTHER

Other Intervention Names

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eicosapentaenoic acid (EPA) docosahexaenoic acid (DHA) marine fatty acids omega-3 fatty acids fish oils cholecalciferol vitamin D3

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes