Evidence map›Paper›PMID 21986389›Full record

Trial reportContemporary clinical trials2012

The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease.

Joann E Manson, Shari S Bassuk, I-Min Lee, Nancy R Cook, Michelle A Albert, David Gordon, Elaine Zaharris, Jean G Macfadyen, Eleanor Danielson, Jennifer Lin and 2 more

3 registry-linked trialsOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 281 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
281citing papers in PubMed, 17 pooled it
29.7field-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.

NCT01169259 phase3active not recruitingnot on this map

Vitamin D and Omega-3 Trial (VITAL)

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2026Enrolled25,871ConditionsCancer, Cardiovascular DiseaseArmsvitamin D3, omega-3 fatty acids (fish oil), Vitamin D3 placebo, Fish oil placebo
NCT01758081 naactive not recruitingnot on this map

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18

TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2026Enrolled25,874ConditionsInfections, Human Cathelicidin Antimicrobial Peptide (hCAP-18)Armsvitamin D3, omega-3 fatty acids (fish oil), Vitamin D3 placebo, fish oil placebo
NCT04005573 nacompletednot on this mapstarted 2019, after this paper: background citation

Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein: a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency

TypeinterventionalSponsorApplied Science Private UniversityRan2019 to 2020Enrolled111ConditionsVitamin D DeficiencyArmsVD3, omega 3- FA, VD3 and omega- 3FA, no intervention
3 · Its place in the literature

Who cites it

281 citing papers in PubMed, 17 syntheses or guidelines pooled it, 552 citations in OpenAlex.

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  16. Guideline
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  18. Vitamin DThe American journal of clinical nutrition · 2025
    Trial
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221 more citing papers are in PubMed but not listed here.

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

12 authors at 2 institutions in 1 country.

Joann E MansonDivision of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, MA 02215, United States. jmanson@rics.bwh.harvard.edu
Shari S Bassuk
I-Min Lee
Nancy R Cook
Michelle A Albert
David Gordon
Elaine Zaharris
Jean G Macfadyen
Eleanor Danielson
Jennifer Lin
Shumin M Zhang
Julie E Buring
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
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaLR01MH091448 · NIMH · BRIGHAM AND WOMEN'S HOSPITAL · PI OKEREKE, OLIVIA IFEOMA · 2010 to 2019
$6.5M
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
Randomized trial of vitamin D and omega-3 fatty acids for diabetic kidney diseaseR01DK088762 · NIDDK · UNIVERSITY OF WASHINGTON · PI DE BOER, IAN H · 2010 to 2019
$4.7M
VITamin D and OmegA-3 TriaL (VITAL): Interrelationship of Vitamin D and Vitamin K on BoneR01AR059775 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LEBOFF, MERYL SUSAN · 2012 to 2022
$3.9M
Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and HypertensionR01HL102122 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI FORMAN, JOHN P, SESSO, HOWARD D · 2011 to 2016
$3.3M
Lung VITamin D and OmegA-3 TriaL (Lung VITAL)R01HL101932 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI GOLD, DIANE R · 2010 to 2014
$3.2M
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive DeclineR01AG036755 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI KANG, JAE H · 2010 to 2015
$2.6M
Diabetes Prevention in the Vitamin D and Omega-3 TrialR01DK088078 · NIDDK · BRIGHAM AND WOMEN'S HOSPITAL · PI PRADHAN, ARUNA DAS, SONG, YIQING · 2010 to 2014
$2.4M
Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on FracturesR01AR060574 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LEBOFF, MERYL SUSAN · 2010 to 2013
$779k
NCI NIH HHS U01 CA138962NHLBI NIH HHS R01 HL101932NHLBI NIH HHS R01 HL102122NIAMS NIH HHS R01 AR059086NIAMS NIH HHS R01AR059086NIAMS NIH HHS R01 AR059775NIAMS NIH HHS R01 AR060574NIAMS NIH HHS R01AR060574NIA NIH HHS R01 AG036755NIDDK NIH HHS R01 DK088078NIDDK NIH HHS R01 DK088762NIMH NIH HHS R01 MH091448NIMH NIH HHS R01MH091448
6 · The paper itself

Abstract

Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2 x 2 factorial trial of vitamin D (in the form of vitamin D(3) [cholecalciferol], 2000 IU/day) and marine omega-3 fatty acid (Omacor fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥ 50 and women aged ≥ 55. The mean treatment period will be 5 years. Baseline blood samples will be collected in at least 16,000 participants, with follow-up blood collection in about 6000 participants. Yearly follow-up questionnaires will assess treatment compliance (plasma biomarker measures will also assess compliance in a random sample of participants), use of non-study drugs or supplements, occurrence of endpoints, and cancer and vascular risk factors. Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment, and deaths will be ascertained through national registries and other sources. Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance; hypertension; cognitive decline; depression; osteoporosis and fracture; physical disability and falls; asthma and other respiratory diseases; infections; and rheumatoid arthritis, systemic lupus erythematosus, thyroid diseases, and other autoimmune disorders.

Indexed as

Dietary SupplementsCardiovascular DiseasesDouble-Blind MethodFatty Acids, Omega-3FemaleFish OilsFollow-Up StudiesHumansMaleMiddle AgedNeoplasmsPrimary PreventionRetrospective StudiesTreatment OutcomeVitamin DVitaminsFatty Acids, Omega-3Fish OilsVitamin DVitamins

Identifiers

PMID21986389
PMCPMC3253961
OpenAlexW2058616836

What OpenQuestion holds

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Read underepoch 390

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.