Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
This study is enrolling participants by invitation only.
Sponsor:
Brigham and Women's Hospital
Collaborator:
Information provided by (Responsible Party):
Karen H. Costenbader, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01351805
First received: May 4, 2011
Last updated: February 4, 2013
Last verified: September 2012
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Purpose
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 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 | Intervention |
|---|---|
|
Autoimmune Diseases Systemic Inflammatory Process Knee Pain Chronic Osteoarthritis Rheumatoid Arthritis |
Drug: Fish Oil Dietary Supplement: Vitamin D Other: placebo pill |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain |
Resource links provided by NLM:
MedlinePlus related topics:
Autoimmune Diseases
Cancer
Dietary Supplements
Osteoarthritis
Rheumatoid Arthritis
Vitamin D
U.S. FDA Resources
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Serum levels of Biomarkers of Systemic Inflammation [ Time Frame: 5 years ] [ Designated as safety issue: No ]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).
- Severity of Knee Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]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).
- Incident Autoimmune Diseases [ Time Frame: 5 years ] [ Designated as safety issue: No ]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:
- Interactions between the effects of vitamin D and those of fish oils for each of the primary outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Subgroup analysis of primary outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 20000 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
|
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:
Dietary Supplement: Vitamin D
Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
Other Names:
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351805
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
| Principal Investigator: | Karen H Costenbader, MD, MPH | Brigham and Women's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Karen H. Costenbader, Associate Physician, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01351805 History of Changes |
| Other Study ID Numbers: | R01 AR059086, R01AR059086 |
| Study First Received: | May 4, 2011 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
vitamin D omega-3 fatty acid fish oil prevention trial autoimmune disease rheumatoid arthritis |
psoriasis systemic inflammation Interleukin-6 C-reactive peptide tumor necrosis factor osteoarthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Autoimmune Diseases Inflammation Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Immune System Diseases |
Pathologic Processes Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013