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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Autoimmune Diseases; Systemic Inflammatory Process; Knee Pain Chronic; Osteoarthritis; Rheumatoid Arthritis	Drug: Fish Oil; Dietary Supplement: Vitamin D; Other: placebo pill	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25876 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Study Start Date :	January 2011
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Fish Oil; Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).	Drug: Fish Oil; Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).; Other Names: eicosapentaenoic acid (EPA); docosahexaenoic acid (DHA); marine fatty acids; omega-3 fatty acids; fish oils
Experimental: Vitamin D; Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.	Dietary Supplement: Vitamin D; Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.; Other Names: cholecalciferol; vitamin D3
Placebo Comparator: placebo; Subjects will receive placebo pill.	Other: placebo pill; placebo
Experimental: 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]).	Drug: Fish Oil; Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).; Other Names: eicosapentaenoic acid (EPA); docosahexaenoic acid (DHA); marine fatty acids; omega-3 fatty acids; fish oils Dietary Supplement: Vitamin D; Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.; Other Names: cholecalciferol; vitamin D3

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Serum levels of Biomarkers of Systemic Inflammation [ Time Frame: 5 years ]
   Blood samples at baseline and in follow-up will be collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein, interleukin-6, and tumor necrosis factor-receptor 2. We will test whether either or both supplements are associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo).
2. Severity of Knee Pain [ Time Frame: 5 years ]
   Participants with chronic, frequent knee pain at trial baseline will be followed with annual questionnaires to test for decrease in severity of chronic knee pain in those taking supplements compared to those taking placebo. We will test whether either or both supplements are associated with reduced levels of knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo).
3. Incident Autoimmune Diseases [ Time Frame: 5 years ]
   All participants will be followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica.

Secondary Outcome Measures :

1. Interactions between the effects of vitamin D and those of fish oils for each of the primary outcomes [ Time Frame: 5 years ]
   We will test for interactions between the effects of vitamin D and those of fish oils for each of the primary outcomes above: (A) whether either or both supplements are associated with reduced numbers of new cases of autoimmune diseases; (B) whether either or both supplements are associated with reductions in biomarkers of systemic inflammation and; (C) whether either or both supplements are associated with reduced levels of knee pain at the end of the trial.
2. Subgroup analysis of primary outcomes [ Time Frame: 5 years ]
   We will test for differential effects of and interactions between vitamin D and fish oils for each of the three primary outcomes, according to participant age, race, sex and BMI. We will test for these interactions for each of the primary aims above: (A) whether either or both supplements are associated with reduced numbers of new cases of autoimmune diseases; (B) whether either or both supplements are associated with reductions in biomarkers of systemic inflammation and; (C) whether either or both supplements are associated with reduced levels of knee pain at the end of the trial.

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:	Karen H Costenbader, MD, MPH	Brigham and Women's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Welcome to the VITAL Study Website 

Responsible Party:	Karen H. Costenbader, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01351805 History of Changes
Other Study ID Numbers:	R01AR059086 ( U.S. NIH Grant/Contract )
First Posted:	May 11, 2011
Last Update Posted:	July 13, 2017
Last Verified:	July 2017

Keywords provided by Karen H. Costenbader, Brigham and Women's Hospital:

autoimmune disease; vitamin D; omega-3 fatty acid; fish oil; prevention; trial; rheumatoid arthritis	psoriasis; systemic inflammation; Interleukin-6; C-reactive peptide; tumor necrosis factor; osteoarthritis

Additional relevant MeSH terms:

Autoimmune Diseases; Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Inflammation; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Immune System Diseases	Pathologic Processes; Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents