Evidence map›Paper›PMID 38272846›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2024

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 and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01351805 (Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
11.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01351805 nacompletednot on this map

Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2025Enrolled25,871ConditionsAutoimmune Diseases, Systemic Inflammatory Process, Knee Pain Chronic, OsteoarthritisArmsFish Oil, Vitamin D, placebo pill
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Vitamin D in inflammatory rheumatic diseases: still a challenge.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Vitamin DFrontiers in immunology · 2026
    Review
  14. Review
  15. Review
  16. Beneficial health effects of ultraviolet radiation: expert review and conference report.Photochemical & photobiological sciences : Official journal of the European Photochemistry Association and the European Society for Photobiology · 2025
    Review
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Karen H CostenbaderBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.ORCID 0000-0002-8972-9388
Nancy R CookBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.ORCID 0000-0002-9705-0842
I-Min LeeBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.
Jill HahnHarvard University, Boston, Massachusetts.
Joseph WalterBrigham and Women's Hospital, Boston, Massachusetts.
Vadim BubesBrigham and Women's Hospital, Boston, Massachusetts.
Gregory KotlerBrigham and Women's Hospital, Boston, Massachusetts.
Nicole YangBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.
Sonia FriedmanBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.
Erik K AlexanderBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.
JoAnn E MansonBrigham and Women's Hospital and Harvard University, Boston, Massachusetts.
Brigham and Women's Hospital · USHarvard University · US

Funding

VITamin D and omegA-3 triaL (VITAL)U01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2009 to 2014
$23.6M
The VITamin D and OmegA-3 TriaL (VITAL)R01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2015 to 2019
$20.9M
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint PainR01AR059086 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2010 to 2021
$5.4M
The VITamin D and OmegA-3 TriaL (VITAL): Post-Intervention Follow-UpR01AT011729 · NCCIH · BRIGHAM AND WOMEN'S HOSPITAL · PI Jun Li, JoAnn Elisabeth Manson · 2021 to 2026
$5.2M
Cardiovascular Disease Epidemiology in Patients with LupusK24AR066109 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2014 to 2023
$1.7M
NCCIH NIH HHS R01 AT011729NCI NIH HHS R01 CA138962NCI NIH HHS U01 CA138962NIAMS NIH HHS K24 AR066109NIAMS NIH HHS R01 AR059086NIH HHS K24-AR-066109NIH HHS R01-AR-059086NIH HHS R01-AT-011729NIH HHS R01-CA-138962
6 · The paper itself

Abstract

objectiveIn the 5.3-year randomized, 2 × 2 factorial, double-blind, placebo-controlled Vitamin D and Omega-3 Trial (VITAL), vitamin D supplementation reduced autoimmune disease (AD) incidence (hazard ratio [HR] 0.78, 95% confidence interval [CI] 0.61-0.99). Omega-3 (n-3) fatty acid supplementation showed a statistically nonsignificant reduction (HR 0.85, 95% CI 0.67-1.08). We aimed to confirm further AD cases arising during and after randomization and assess sustained effects with two years of postintervention observation.

methodsOf the 12,786 men aged ≥50 and 13,085 women aged ≥55 initially randomized, we observed surviving and willing participants for two more years. We continued to confirm annual participant-reported new AD by medical record review. Cox models calculated HRs for all confirmed incident AD, (and secondary endpoints, including probable cases, and individual ADs), during the observational and randomized periods.

resultsA total of 21,592 participants (83.5%) were observed for two more years; 514 participants developed incident confirmed AD (236 since prior report), of whom 255 had been randomized to vitamin D versus 259 to vitamin D placebo (HR 0.98 [95% CI 0.83-1.17] at 7 years). AD was confirmed in 234 participants initially randomized to n-3 fatty acids versus 280 randomized to its placebo (HR 0.83 [95% CI 0.70-0.99] at 7 years). Of newly confirmed cases, 65 had onset during randomization; their inclusion changed randomized results as follows: HR 0.85 (95% CI 0.70-1.04) for vitamin D and HR 0.87 (95% CI 0.71-1.06) for n-3 fatty acids.

conclusionTwo years after trial termination, the protective effects of 2000 IU/day of vitamin D dissipated, but 1,000 mg/day of n-3 fatty acids had a sustained effect in reducing AD incidence.

Indexed as

Autoimmune DiseasesDietary SupplementsFatty Acids, Omega-3Vitamin DAgedDouble-Blind MethodFemaleHumansIncidenceMaleMiddle AgedProportional Hazards ModelsTreatment OutcomeFatty Acids, Omega-3Vitamin D

Identifiers

PMID38272846
PMCPMC11565399
OpenAlexW4391238354

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.