Tier 1 — highest

Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial

Jill Hahn, Nancy R Cook, Erik K Alexander, Sonia Friedman, Joseph Walter, Vadim Bubes, Gregory Kotler, I-Min Lee, JoAnn E Manson, Karen H Costenbader
BMJ (Clinical research ed.) 2022 376:e066452

Bibliography

PubMed
PMID 35082139
PubMed Central
PMC8791065
DOI
10.1136/bmj-2021-066452
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Support is recorded from NIAMS NIH HHS, NCCIH NIH HHS, NCI NIH HHS. See the original publication for grant and material-support details.
Competing interests
The authors report no relevant competing interests.

Study snapshot

DesignRandomized controlled clinical trial
ModelHuman participants
Sample25,871 VITAL participants
InterventionVitamin D3 2,000 IU/day and/or omega-3 1 g/day, with matched placebos
DurationMedian 5.3 years
EndpointsConfirmed incident autoimmune disease

What the study showed, in plain terms

This publication examines confirmed incident autoimmune disease. Study population or evidence base: 25,871 VITAL participants. Intervention or exposure: Vitamin D3 2,000 IU/day and/or omega-3 1 g/day, with matched placebos.

Key findings

The initial analysis reported fewer confirmed autoimmune diseases with vitamin D during treatment. The estimate was borderline statistically significant and was revised in a later follow-up report.

What this study can and cannot tell us

The updated 2024 publication adds previously unconfirmed cases and post-treatment follow-up. Both reports should be considered together, rather than treating the initial estimate as final.

Related papers in the corpus

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Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
JoAnn E Manson et al. · The New England journal of medicine · 2019
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Olivia I Okereke et al. · JAMA · 2020
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Vitamin D supplementation vs. placebo and incident type 2 diabetes in an ancillary study of the randomized Vitamin D and Omega-3 Trial
Deirdre K Tobias et al. · Nature communications · 2025
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Effects of Vitamin D3 and Marine Omega-3 Fatty Acids Supplementation on Biomarkers of Systemic Inflammation: 4-Year Findings from the VITAL Randomized Trial
Yanbin Dong et al. · Nutrients · 2022

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