N/A
Completed N=25,871
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain
autoimmune disorders · Systemic Inflammatory Process · Knee Pain Chronic · Osteoarthritis
Source: ClinicalTrials.gov NCT01351805 ↗
Enrolled (actual)
25,871
Serious AEs
12.5%
Results posted
Jan 2021
Primary outcomePrimary: Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6) — 1.71; 1.68; 1.69; 1.70 pg/ml — p=0.02
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.
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 |
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. Informational only — not medical advice.