Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial
Hahn J, Cook NR, Alexander EK, Friedman S, Walter J, Bubes V, Kotler G, Lee IM, Manson JE, Costenbader KH
BMJ (Clinical research ed.) · 282 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Independent funding
- Government
- National Institutes of Health
- Government
- National Cancer Institute
- Government
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Government
- National Center for Complementary and Integrative Health
- Government
- NCI NIH HHS
- Government
- NCCIH NIH HHS
- Government
- NIAMS NIH HHS
- Grants
- National Cancer Institute (R01 CA138962); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059086); National Center for Complementary and Integrative Health (R01 AT011729)
Based on 7 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2022-01-26 · BMJ · vol. 376 · p. e066452
- Cited
- 418 citations · more than 100% of similar papers · 52.4× the field average
- Impact
- Top 10% most cited in its field
- References
- 40 works
- Access
- Open access (hybrid journal) · CC-BY-NC
- Research areas
- Vitamin D Research Studies · Fatty Acid Research and Health · Spondyloarthritis Studies and Treatments
- Keywords
- Medicine, Hazard ratio, Internal medicine, Rheumatoid arthritis, Vitamin D and neurology, Clinical endpoint, Placebo, Randomized controlled trial, Gastroenterology, Confidence interval, Pathology
- MeSH
- humans, autoimmune diseases, cholecalciferol, fatty acids, omega-3, treatment outcome, incidence, follow-up studies, double-blind method, dietary supplements, aged, middle aged, female, male
10 authors
From US
- Jill HahnBrigham and Women's Hospital; Harvard University
- Nancy R. CookBrigham and Women's Hospital; Harvard University
- Erik Karl AlexanderBrigham and Women's Hospital; Harvard University
- Sonia FriedmanBrigham and Women's Hospital
- Joseph N. WalterBrigham and Women's Hospital; Harvard University
- Vadim Y. BubesBrigham and Women's Hospital; Harvard University
Abstract
Objective
To investigate whether vitamin D and marine derived long chain omega 3 fatty acids reduce autoimmune disease risk.
Design
Vitamin D and omega 3 trial (VITAL), a nationwide, randomized, double blind, placebo controlled trial with a two-by-two factorial design.
Setting
Nationwide in the United States.
Participants
25 871 participants, consisting of 12 786 men ≥50 years and 13 085 women ≥55 years at enrollment.
Interventions
Vitamin D (2000 IU/day) or matched placebo, and omega 3 fatty acids (1000 mg/day) or matched placebo. Participants self-reported all incident autoimmune diseases from baseline to a median of 5.3 years of follow-up; these diseases were confirmed by extensive medical record review. Cox proportional hazard models were used to test the effects of vitamin D and omega 3 fatty acids on autoimmune disease incidence.
Main outcome measures
The primary endpoint was all incident autoimmune diseases confirmed by medical record review: rheumatoid arthritis, polymyalgia rheumatica, autoimmune thyroid disease, psoriasis, and all others.
Results
25 871 participants were enrolled and followed for a median of 5.3 years. 18 046 self-identified as non-Hispanic white, 5106 as black, and 2152 as other racial and ethnic groups. The mean age was 67.1 years. For the vitamin D arm, 123 participants in the treatment group and 155 in the placebo group had a confirmed autoimmune disease (hazard ratio 0.78, 95% confidence interval 0.61 to 0.99, P=0.05). In the omega 3 fatty acids arm, 130 participants in the treatment group and 148 in the placebo group had a confirmed autoimmune disease (0.85, 0.67 to 1.08, P=0.19). Compared with the reference arm (vitamin D placebo and omega 3 fatty acid placebo; 88 with confirmed autoimmune disease), 63 participants who received vitamin D and omega 3 fatty acids (0.69, 0.49 to 0.96), 60 who received only vitamin D (0.68, 0.48 to 0.94), and 67 who received only omega 3 fatty acids (0.74, 0.54 to 1.03) had confirmed autoimmune disease.
Conclusions
Vitamin D supplementation for five years, with or without omega 3 fatty acids, reduced autoimmune disease by 22%, while omega 3 fatty acid supplementation with or without vitamin D reduced the autoimmune disease rate by 15% (not statistically significant). Both treatment arms showed larger effects than the reference arm (vitamin D placebo and omega 3 fatty acid placebo).
Study registration
ClinicalTrials.gov NCT01351805 and NCT01169259.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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