Tier 1 — highest

Vitamin D and Marine n-3 Fatty Acids for Autoimmune Disease Prevention: Outcomes Two Years After Completion of a Double-Blind, Placebo-Controlled Trial

Karen H Costenbader, Nancy R Cook, I-Min Lee, Jill Hahn, Joseph Walter, Vadim Bubes, Gregory Kotler, Nicole Yang, Sonia Friedman, Erik K Alexander, JoAnn E Manson
Arthritis & rheumatology (Hoboken, N.J.) 2024 76(6):973-983

Bibliography

PubMed
PMID 38272846
PubMed Central
PMC11565399
DOI
10.1002/art.42811
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Support is recorded from NIH HHS, NCCIH NIH HHS, NIAMS NIH HHS, NCI NIH HHS. See the original publication for grant and material-support details.
Competing interests
A competing-interest declaration is not available in the indexed abstract or accessible disclosure metadata.

Study snapshot

DesignPost-intervention follow-up of a randomized factorial trial
ModelHuman participants
Sample21,592 surviving and willing VITAL participants followed after treatment
InterventionPrior assignment to D3 2,000 IU/day and/or omega-3; no continuing randomized treatment
Duration2 years after the median 5.3-year intervention
EndpointsConfirmed autoimmune disease during and after treatment

What the study showed, in plain terms

This publication examines confirmed autoimmune disease during and after treatment. Study population or evidence base: 21,592 surviving and willing VITAL participants followed after treatment. Intervention or exposure: Prior assignment to D3 2,000 IU/day and/or omega-3; no continuing randomized treatment.

Key findings

The vitamin D-associated reduction was no longer apparent over seven years. Adding newly confirmed cases also weakened the original treatment-period vitamin D estimate.

What this study can and cannot tell us

Post-treatment observation is not continued randomized supplementation. This updates the same VITAL autoimmune study and should be linked to its initial report.

Related papers in the corpus

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JoAnn E Manson et al. · The New England journal of medicine · 2019
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Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults
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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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