Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
25119 participants
INTERVENTIONAL
2012-10-31
2026-10-31
Brief Summary
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Detailed Description
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Investigators will ascertain atrial fibrillation events utilizing self-report of physician diagnoses of atrial fibrillation received on annual questionnaires from study participants supplemented by outpatient and hospital visits for AF identified through Centers for Medicare and Medicaid Services (CMS) data linkage. Investigators will also ascertain additional information regarding atrial fibrillation diagnosis from supplementary questionnaires, and seek consent to review all inpatient and outpatient hospital records pertaining to atrial fibrillation diagnosis and evaluation. Atrial fibrillation events will be confirmed by an endpoint committee composed of cardiologists, which will also make 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 fibrillation subtype and progression. An intention-to-treat analysis examining the 5-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 will repeat these analyses at the end of extended follow-up to assess cumulative and post-treatment effects of omega-3 fatty acids and vitamin D and AF subtypes two years after diagnosis.
Electrocardiograms will be obtained at baseline and again after two years of treatment and follow-up among a sub-cohort of 1,054 patients being enrolled in VITAL at the CTSC. Investigators will utilize these ECG data to evaluate whether treatment with omega-3 fatty acids and vitamin D3 have significant effects on ECG measures. The ECGs will also be utilized to estimate the prevalence of asymptomatic persistent atrial fibrillation in our population not detected by our atrial fibrillation surveillance methods.
Investigators will examine baseline blood samples for participants with confirmed atrial fibrillation for the purpose of exploring whether the effect of vitamin D3 or fish oil supplementation on atrial fibrillation risk varies by the baseline blood levels of these nutrients.
Investigators will also seek additional information necessary to classify deaths as sudden or arrhythmic in origin, and cardiac deaths will be reviewed by an endpoint committee of cardiologists. Once these results have been compiled investigators will explore whether omega-3 fatty acids and/or vitamin D might have an effect on sudden and/or arrhythmic cardiac death.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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Vitamin D + fish oil
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Vitamin D + fish oil placebo
Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Fish oil placebo
Fish oil placebo
Vitamin D placebo + fish oil
Omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Vitamin D3 placebo
Vitamin D3 placebo
Vitamin D placebo + fish oil placebo
Fish oil placebo
Fish oil placebo
Vitamin D3 placebo
Vitamin D3 placebo
Interventions
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Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Omega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Fish oil placebo
Fish oil placebo
Vitamin D3 placebo
Vitamin D3 placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
and/or
\- cardiovascular death
Exclusion Criteria
50 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cedars-Sinai Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Christine M. Albert, MD, MPH
Principle Investigator
Principal Investigators
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Christine M. Albert, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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, Garg P, Tsai MY, Pankow J, Misialek JR, Gigante B, Leander K, Pester JA, Albert CM, Kavousi M, Ikram A, Voortman T, Schmidt EB, Ninomiya T, Morrow DA, Bayes-Genis A, O'Keefe JH, Ong KL, Wu JHY, Mozaffarian D, Harris WS, Siscovick DS; Fatty Acids and Outcomes Research Consortium (FORCE). Omega-3 Fatty Acid Biomarkers and Incident Atrial Fibrillation. J Am Coll Cardiol. 2023 Jul 25;82(4):336-349. doi: 10.1016/j.jacc.2023.05.024.
Gencer B, Djousse L, Al-Ramady OT, Cook NR, Manson JE, Albert CM. Effect of Long-Term Marine ɷ-3 Fatty Acids Supplementation on the Risk of Atrial Fibrillation in Randomized Controlled Trials of Cardiovascular Outcomes: A Systematic Review and Meta-Analysis. Circulation. 2021 Dec 21;144(25):1981-1990. doi: 10.1161/CIRCULATIONAHA.121.055654. Epub 2021 Oct 6.
Middeldorp ME, Sandhu RK, Mao J, Gencer B, Danik JS, Moorthy V, Cook NR, Albert CM. Risk Factors for the Development of New-Onset Persistent Atrial Fibrillation: Subanalysis of the VITAL Study. Circ Arrhythm Electrophysiol. 2023 Dec;16(12):651-662. doi: 10.1161/CIRCEP.123.012334. Epub 2023 Nov 29.
Siddiqi HK, Vinayagamoorthy M, Gencer B, Ng C, Pester J, Cook NR, Lee IM, Buring J, Manson JE, Albert CM. Sex Differences in Atrial Fibrillation Risk: The VITAL Rhythm Study. JAMA Cardiol. 2022 Oct 1;7(10):1027-1035. doi: 10.1001/jamacardio.2022.2825.
Albert CM, Cook NR, Pester J, Moorthy MV, Ridge C, Danik JS, Gencer B, Siddiqi HK, Ng C, Gibson H, Mora S, Buring JE, Manson JE. Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation: A Randomized Clinical Trial. JAMA. 2021 Mar 16;325(11):1061-1073. doi: 10.1001/jama.2021.1489.
Tikkanen JT, Soliman EZ, Pester J, Danik JS, Gomelskya N, Copeland T, Lee IM, Buring JE, Manson JE, Cook NR, Albert CM. A randomized clinical trial of omega-3 fatty acid and vitamin D supplementation on electrocardiographic risk profiles. Sci Rep. 2023 Jul 15;13(1):11454. doi: 10.1038/s41598-023-38344-x.
Related Links
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Welcome to the VITAL Study website
Other Identifiers
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2012P002146
Identifier Type: -
Identifier Source: org_study_id
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