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

This study is ongoing, but not recruiting participants.
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: June 4, 2014
Last verified: June 2014

May 4, 2011
June 4, 2014
January 2011
October 2017   (final data collection date for primary outcome measure)
  • 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.
  • Effects on 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).
  • Effect upon Chronic Frequent Knee Pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Participants with chronic, frequent knee pain at trial basline will be followed with annual questionnaires to evaluate the supplement effects upon chronic knee pain. 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 theose receiving supplements to placebo).
  • Prevention Incident Autoimmune Diseases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    We will test whether either or both supplements decrease the number of new cases of autoimmune diseases (number of cases of incident autoimmune disease among those receiving supplements vs. placebo).
Complete list of historical versions of study NCT01351805 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Safety of the supplements alone and in combination for 5 years in an older American population. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    We will assess safety of the supplements alone and in combination for 5 years in an older American population. We will test for whether there are differences in the numbers of adverse events reported among those taking either fish oil or vitamin D and those receiving placebo pills.
  • Subgroup analyses: effects according to age; effects in men and women; effects in different racial groups and effects according to body mass index (BMI) [ 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 priamry 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.
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Not Provided
 
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain

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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Autoimmune Diseases
  • Systemic Inflammatory Process
  • Knee Pain Chronic
  • Osteoarthritis
  • Rheumatoid Arthritis
  • 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
  • Other: placebo pill
    placebo
  • Experimental: Fish Oil
    Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
    Intervention: Drug: Fish Oil
  • Experimental: Vitamin D
    Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: placebo
    Subjects will receive placebo pill.
    Intervention: Other: placebo pill
  • 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]).
    Interventions:
    • Drug: Fish Oil
    • Dietary Supplement: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25876
October 2017
October 2017   (final data collection date for primary outcome measure)

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.

Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01351805
R01 AR059086, R01AR059086
Yes
Karen H. Costenbader, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Karen H Costenbader, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP