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

This study is enrolling participants by invitation only.
Sponsor:
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: October 17, 2013
Last verified: October 2013
  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:


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:
  • 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

  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: October 17, 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 April 17, 2014