N/A
N=25,871
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
Autoimmune Diseases · Systemic Inflammatory Process · Knee Pain Chronic · Osteoarthritis · Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01351805 ↗Enrolled (actual)
25,871
Serious AEs
12.5%
Results posted
Jan 2021
Primary outcome: Primary: Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6) — 1.71; 1.68; 1.69; 1.70 pg/ml — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fish Oil (Drug); Vitamin D (Dietary_supplement); placebo pill (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6) |
1.71; 1.68; 1.69; 1.70; 1.80; 1.63 | 0.02 sig |
| PRIMARY Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP) |
1.48; 1.51; 1.57; 1.43; 1.62; 1.54 | 0.16 |
| PRIMARY Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2) |
2546.5; 2525.4; 2571.3; 2500.9; 2604.7; 2567.9 | 0.57 |
| PRIMARY Incident Autoimmune Diseases |
123; 155; 130; 148 | 0.05 |
| PRIMARY Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA & Vitamin D |
36.5; 35.4; 35.4; 36.5; 33.6; 33.7 | 0.77 |
| SECONDARY Incident Autoimmune Disease |
255; 259; 234; 280 | <0.05 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01351805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.