2026-07-14
minor
Study Status, Oversight, Outcome Measures (Results), Adverse Events v36
Completion pushed: 2026-05 → 2026-10
2025-10-22
minor
Study Status, Oversight, Outcome Measures (Results), Adverse Events v35
Completion date2026-05-31→2026-05
2025-09-18
minor
Study Status, Outcome Measures, Outcome Measures (Results) v34
Completion date2025-02→2026-05-31
Secondary endpointsdetails revised at 9 of 11 entries
Show 26 earlier versions
2020-07-15
minor
Study Status, Outcome Measures, References, Outcome Measures (Results) v26
Publicationsdetails revised at 2 of 39 entries
2020-01-03
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing, Document Section, Participant Flow, Baseline Characteristics v25
Results first postednot stated→2020-01-06
Eligibility criteria+78 characters
[...] attack, stroke, transient ischemic attack, angina pectoris, CABGcoronary-artery bypass grafting, or PCIpercutaneous coronary intervention;
have none of the following safety exclusions: history of r [...] anulomatous diseases such as active chronic tuberculosis or granulomatosis with polyangiitis (Wegener's granulomatosis);
have no allergy to fish or soy;
have no other serious illn [...]
Secondary endpoints9 to 11 entries
Number of Participants Who Died From Invasive Cancer of Any Type
Number of Female Participants With Breast Cancer
Number of Male Participants With Prostate Cancer
Number of Participants With Colorectal cancerCancer
BreastNumber cancerof (Participants With Cardiovascular Event in women)
Prostate cancer (in men)
Total cancer mortality
Expanded CVDComposite eventsCardiovascular Endpoint
CVDNumber mortality
of Participants With Myocardial infarctionInfarction
Number of Participants With Stroke
TotalNumber mortalityof Participants Who Died From Cardiovascular Causes
Number of Participants Who Died [...]
Primary endpoints2 entries, revised
Number of Participants With Invasive Cancer of Any Type
Number of Participants With a Major CVDCardiovascular events
Total cancerEvent
Study description+501 characters
[...] h adequate dosing in general populations are lacking.
VITAL will testtested the independent effects of vitamin D and omega-3 fatty acid [...] tcomes are specified in the Outcome Measures section).
VITAL will also exploreexplored (a) whether vitamin D and omega-3 fatty acid supplements ex [...] ment on cancer and CVD risk varies by baseline blood levels or intake of vitamin D and EPA+DHA, race/ethnicity (for vitamin D), and body mass index (for vitamin D), as well as age, sex, sunlight exposure, calcium and phosphorus intakesintake, and baseline risk factors for cancer and CVD.
Eligible par [...] tting at least one [...]
Collaborators5 to 8 entries
Pharmavite LLC
Pronova BioPharma
BASF
2019-10-17
minor
Study Status v24
Primary completion date2018-11→2018-11-10
2019-07-08
minor
Study Status v23
Re-verified, no change to tracked fields
2019-01-15
minor
Study Status, Study Description, References v22
Completion date2018-11→2020-11
Study description-9 characters
The VITamin D and OmegA-3 TriaL (VITAL) is an ongoinga randomized clinical trial of vitamin D (in the form of vita [...]
Publicationsdetails revised at 2 of 39 entries
2018-07-09
minor
Study Status v21
Primary completion date2018-06→2018-11
Completion date2018-06→2018-11
2018-04-06
minor
2 amendments v19-v20
2 re-verifications since 2018-01-16, no change to tracked fields
2017-09-29
minor
Study Status, Study Description, Outcome Measures, References v18
Primary completion date2017-12→2018-06
Completion date2017-12→2018-06
Secondary endpoints+169 characters
Colorectal cancer
Breast cancer (in women)
Prostate cancer (in men)
Total cancer mortality
Expanded CVD events
CVD mortality
Myocardial infarction
Stroke
Total mortality
Primary endpoints1 to 2 entries
Major CVD events
Total cancer and cardiovascular disease
Study description+665 characters
[...] the primary prevention of cancer and cardiovascular disease (CVD).
Existing data from laboratory studies, epidemiologic resea [...] that these nutritional agents may reduce risk for cancer or cardiovascular diseaseCVD, but large primary prevention trials with adequate dosing in general populations are lacking.
VITAL will test the independent effects of vitamin D and omega-3 fatty acid supplementation on risk for developing cancer and CVD (primary, secondary, and other outcomes are specified in the Outcome Measures section).
VITAL will also explore (a) whether vitamin D and omega-3 fatty acid supplem [...] [...]
Publications38 to 39 entries
Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. 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 p [...]
2017-05-11
minor
Study Status, Study Description, Study Design v17
Enrollment target25874→25871
Study descriptionrevised
[...] to clarify responses on the questionnaire.
At baseline, 16,956954 VITAL participants provided an optional blood sample.
Appro [...]
2016-05-10
minor
Study Status v16
Primary completion date2017-10→2017-12
Completion date2017-10→2017-12
2016-04-12
minor
Study Status, Study Description v15
Study description+862 characters
[...] ct information or to clarify responses on the questionnaire.
At baseline, 16,956 VITAL participants provided an optional blood sample.
Approximately 6,000 of these participants will provide a follow-up blood sample during years 1-4 of the trial.
At baseline and year 2 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Bos [...]
2016-01-07
minor
Study Status v14
Re-verified, no change to tracked fields
2015-07-10
minor
Study Status, Study Description, Study Design v13
Enrollment target25875→25874
2014-12-05
minor
2 amendments v11-v12
2 re-verifications since 2014-08-04, no change to tracked fields
2014-04-04
notable
Recruiting→Active, Not Recruiting Study Status, Study Description, Study Design, Eligibility, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2016-06→2017-10
Completion date2016-06→2017-10
Enrollment targetestimated 20000→confirmed 25875
Eligibility criteria-17 characters
Respondents willTo be eligible for trialthe participationstudy, ifrespondents theyhad meetto, theseat criteriastudy entry,:
arebe men aged 50 or moreolder or women aged 55 or moreolder;
have no history of cancer (except non-melanoma skin cancer [...] no other serious illness that would preclude participation;
arebe consuming no more than 800 IU of vitamin D from all supplem [...] g, willing to decrease or forego such use during the trial;
arebe consuming no more than 1200 mg/d of calcium from all supple [...] g, willing to decrease or forego such use during the trial;
arenot notbe taking fish oil supplements, or, [...]
Study description-10 characters
The VITamin D and OmegA-3 TriaL (VITAL) is aan ongoing randomized clinical trial of vitamin D (in the form of vita [...] g in general populations are lacking.
Eligible participants will bewere assigned by chance (like a coin toss) to one of four groups [...] ) daily vitamin D placebo and omega-3 placebo.
Participants havehad an equal chance of being assigned to any of these four grou [...] etting at least one active agent.
Participants in all groups will take two pills each day -- one softgel that contains either [...] hat contains either omega-3 or omega-3 placebo.
Participants will receive their study pills in convenie [...] [...]
Study sitesdetails revised at 1 of 1 site
2013-12-13
minor
4 amendments v6-v9
4 re-verifications since 2012-10-03, no change to tracked fields
2012-07-30
minor
Study Status, Study Design, Arms and Interventions v5
PhaseNot applicable→Phase 3
InterventionsFish oil placebo (Dietary Supplement), Vitamin D3 placebo (Dietary Supplement), omega-3 fatty acids (fish oil) (Dietary Supplement)…→Fish oil placebo (Dietary Supplement), Vitamin D3 placebo (Dietary Supplement), omega-3 fatty acids (fish oil) (Drug), vitamin D3 (Dietary…
2012-05-08
minor
Study Status, Eligibility v4
Eligibility criteria-39 characters
[...] criteria:
are men aged 50 or more or women aged 55 or more;
have at least a high school education;
have no history of cancer (except non-melanoma skin cancer), [...]
2011-10-18
minor
Study Status, Sponsor/Collaborators, Eligibility v3
Eligibility criteria-8 characters
Respondents will be eligible for trial participation if they meet these criteria:
are men aged 6050 or more or women aged 6555 or more;
have at least a high school education;
have no his [...] CI;
have none of the following safety exclusions: history of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperpar [...] culosis or Wegener's granulomatosis;
have no allergy to fish or soy;
have no other serious illness that would preclude particip [...]
2011-01-20
minor
Study Status, Sponsor/Collaborators v2
Collaborators2 to 5 entries
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
2010-10-13
minor
Study Status, Study Description v1
Start date2010-03→2010-07
Study description+84 characters
[...] n equal chance of being assigned to any of these four groups and a 3 out of 4 chance of getting at least one active agent.
Participants in all groups will take two pills each day -- [...] t, and smoking; use of medications and dietary supplements; and family history of illness, and new medical diagnoses.
Occasionally, participants may receive a phone call from s [...]