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VITAL Rhythm Study

StatusActive, Not Recruiting
PhasePhase 3
Started2012-10
View on ClinicalTrials.gov ↗

Amendment history

2025-10-02
Study Status, Sponsor/Collaborators, Oversight, References v14
Primary completion date2024-01→2026-10
Completion date2024-01→2026-10
Collaborators1 to 2 entries
Cedars-Sinai Medical Center
Publications2 to 6 entries
Qian F, Tintle N, Jensen PN, Lemaitre RN, Imamura F, Feldreich TR, Nomura SO, Guan W, Laguzzi F, Kim E, Virtanen JK, Steur M, Bork CS, Hirakawa Y, O'Donoghue ML, Sala-Vila A, Ardisson Korat AV, Sun Q, Rimm EB, Psaty BM, Heckbert SR, Forouhi NG, Wareham NJ, Marklund M, Riserus U, Lind L, Arnlov J, Ga [...]
2022-07-19
Study Identification, Study Status v13
Primary completion date2022-06→2024-01
Completion date2022-06→2024-01
2022-03-02
Study Status, Study Design v12
Primary completion date2021-04→2022-06
Completion date2021-04→2022-06
Enrollment target25871→25119
2020-10-22
Study Status v11
Re-verified, no change to tracked fields
2020-05-04
Study Status, Study Description, Study Design v10
Enrollment target25874→25871
Show 9 earlier versions
2019-09-12
Study Status, Study Description, Outcome Measures v9
Secondary endpoints1 to 2 entries
Atrial Fibrillation
Study description+566 characters
[...] a determination on atrial fibrillation subtype and pattern. Questionnaires that inquire about recurrent atrial fibrillation events, pattern of AF, latest medical record evaluation and treatments for AF will be sent to participants with confirmed atrial fibrillation. Medical records will be requested and reviewed an endpoint committee to determine atrial fibr [...] An intention-to-treat analysis examining the main5-year treatment effects of omega-3 fatty acids and vitamin D on incident atrial fibrillation, as well as subtypes at the time of diagnosis will be performed to address the primary aims. We w [...] [...]
2018-05-16
Study Status v8
Primary completion date2018-04→2021-04
Completion date2018-04→2021-04
2017-09-29
Study Status, Contacts/Locations v7
Re-verified, no change to tracked fields
2017-03-29
Study Status, Study Description, Study Design v6
Primary completion date2017-10→2018-04
Completion date2017-10→2018-04
Enrollment target25875→25874
2016-10-05
4 amendments v2-v5
4 re-verifications since 2015-03-04, no change to tracked fields
2014-06-30
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
PhaseNot specified→Phase 3
Study arms1→4
Interventionsnot stated→Fish oil placebo (Dietary Supplement), Omega-3 fatty acids (fish oil) (Drug), Vitamin D3 (Dietary Supplement), Vitamin D3 placebo (Dietary…
Eligibility criteria+34 characters
To be eligibileeligible for thethis ancillary study participants must be enrolled in the VitajminVitamin D and Omega-3 Trial (VITAL; -National Clinical Trial (NCT) 01169259) and meet the following criteria: Inclusion Criteria: - physician diagnosis of atrial fibrillation after randomzationrandomization and/or - cardiovascular death Exclusion Criteria: 1.- initialphysician diagnosis of atrial fibrillation occurred prior to randomization
Study description-1 characters
[...] t detected by our atrial fibrillation surveillance methods. InvestiagatorsInvestigators will examine baseline blood samples for an estimated 500 pa [...]
2014-06-26
Original filing
The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in individuals who do not have a prior history of these illnesses. The purpose of this ancillary study is to ascertain and adjudicate atrial fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or vitamin D supplementation influence atrial fibrillation risk in the general population. We also plan to examine how these agents might impact the development of AF subtypes (persistent versus paroxysmal), intermediate phenotypes for heart rhythm disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death and whether baseline blood levels and/or race modify treatment effects.
Trial Details
NCT Number NCT02178410
Lead Sponsor Brigham and Women's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center
Conditions Cardiovascular Disease
Enrollment 25,119 participants
Start Date 2012-10
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-10-07