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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01351805
Recruitment Status : Active, not recruiting
First Posted : May 11, 2011
Results First Posted : January 8, 2021
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Karen H. Costenbader, Brigham and Women's Hospital

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25871 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
Actual Study Start Date : November 2011
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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

Other: placebo pill
placebo

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

Other: placebo pill
placebo

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




Primary Outcome Measures :
  1. Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6) [ Time Frame: Baseline and 1 year ]
    In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo).

  2. Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP) [ Time Frame: Baseline and 1 year ]
    In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo).

  3. Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2) [ Time Frame: Baseline and 1 year ]
    In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo).

  4. Incident Autoimmune Diseases [ Time Frame: 5 years (Data are not yet published. They are under review at journal and embargoed.) ]

    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.

    Data are not yet published. They are under review at journal and embargoed.



Secondary Outcome Measures :
  1. Interactions Between the Effects of Vitamin D and Those of Fish Oils for Each of the Primary Outcomes. Reported With Main Results. [ Time Frame: 5 years (Data are not yet published. They are under review at journal and embargoed.) ]

    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.

    Data are not yet published. They are under review at journal and embargoed.


  2. Subgroup Analysis of Primary Outcomes. Reported With Main Results, Primary Outcomes. [ Time Frame: 5 years (Data are not yet published. They are under review at journal and embargoed.) ]

    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.

    Data are not yet published. They are under review at journal and embargoed.


  3. Incident Autoimmune Disease [ Time Frame: 8 years (Data are not yet published. They are under review at journal and embargoed.) ]

    Development of new autoimmune diseases through open-label extension beyond the randomized 5 years

    Data are not yet published. They are under review at journal and embargoed.



Other Outcome Measures:
  1. Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA [ Time Frame: Baseline and 5 years ]

    Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain was the primary outcome on a scale of 0-100 with 100= worst pain.

    Subsample of VITAL participants with chronic, frequent knee pain at trial baseline were followed with annual WOMAC questionnaires to test for change in severity of chronic knee pain in those taking Omega-3 fish oil (n-3 FA) supplements compared to those taking placebo. We tested whether n-3 FA supplements are associated with reduced levels of WOMAC knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo).


  2. Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With Vitamin D [ Time Frame: Baseline and 5 years ]

    Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain was the primary outcome on a scale of 0-100 with 100= worst pain.

    Subsample of VITAL participants with chronic, frequent knee pain at trial baseline were followed with annual WOMAC questionnaires to test for change in severity of chronic knee pain in those taking Vitamin D supplements compared to those taking placebo. We tested whether Vitamin D supplements were associated with reduced levels of WOMAC knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo).




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351805


Locations
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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
Layout table for investigator information
Principal Investigator: Karen H Costenbader, MD, MPH Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Karen H. Costenbader, Brigham and Women's Hospital:
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen H. Costenbader, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01351805    
Other Study ID Numbers: R01AR059086 ( U.S. NIH Grant/Contract )
R01AR059086 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2011    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: April 12, 2021
Last Verified: March 2021
Keywords provided by Karen H. Costenbader, 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:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Connective Tissue Diseases
Immune System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents