VITAL Rhythm Study
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ClinicalTrials.gov Identifier: NCT02178410 |
Recruitment Status :
Active, not recruiting
First Posted : June 30, 2014
Last Update Posted : July 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease | Dietary Supplement: Vitamin D3 Drug: Omega-3 fatty acids (fish oil) Dietary Supplement: Fish oil placebo Dietary Supplement: Vitamin D3 placebo | Phase 3 |
Atrial fibrillation and sudden cardiac death assessments, as well as blood analyses, will be conducted on the entire VITAL Study population, and ECG analyses will be limited to the Clinical and Translational Science Center (CTSC) sub-cohort of 1,054 VITAL participants who live near the Boston area and agree to participate in a series of ancillary studies in addition to the main trial.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25119 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Vitamin D and Omega-3 Trial (VITAL Rhythm Study) |
Study Start Date : | October 2012 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | January 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin D + fish oil |
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol Drug: 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]). |
Active Comparator: Vitamin D + fish oil placebo |
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol Dietary Supplement: Fish oil placebo Fish oil placebo |
Active Comparator: Vitamin D placebo + fish oil |
Drug: 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]). Dietary Supplement: Vitamin D3 placebo Vitamin D3 placebo |
Placebo Comparator: Vitamin D placebo + fish oil placebo |
Dietary Supplement: Fish oil placebo
Fish oil placebo Dietary Supplement: Vitamin D3 placebo Vitamin D3 placebo |
- Atrial Fibrillation [ Time Frame: 7 years ]To assess whether omega-3 fatty acids (Omacor® 840 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) or vitamin D3 supplementation influences risk of atrial fibrillation in a general population of men and women without prior cardiovascular disease.
- Atrial Fibrillation [ Time Frame: 7 years ]To examine the short and long-term impacts of vitamin D3 and EPA+DHA supplementation on the development of AF subtypes.
- Arrhythmic endpoints [ Time Frame: 5 years ]To examine the effect of vitamin D3 or EPA+DHA supplementation on electrocardiographic parameters to further understand mechanisms underlying associations with arrhythmic endpoints.
- Sudden Cardiac Death [ Time Frame: 5 years ]To explore effects of arrhythmic death and whether baseline blood levels and/or race modify treatment effects.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
To be eligible this ancillary study participants must be enrolled in the Vitamin D and Omega-3 Trial (VITAL; National Clinical Trial (NCT) 01169259) and meet the following criteria:
Inclusion Criteria:
- physician diagnosis of atrial fibrillation after randomization
and/or
- cardiovascular death
Exclusion Criteria:
- physician diagnosis of atrial fibrillation prior to randomization

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178410
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Christine M. Albert, M.D., M.P.H. | Brigham and Women's Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Christine M. Albert, MD, MPH, Principle Investigator, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT02178410 |
Other Study ID Numbers: |
2012P002146 R01HL116690 ( U.S. NIH Grant/Contract ) |
First Posted: | June 30, 2014 Key Record Dates |
Last Update Posted: | July 21, 2022 |
Last Verified: | July 2022 |
Atrial Fibrillation Vitamin D3 Omega-3 fatty acids Fish oil |
Cardiovascular Diseases Vitamin D Ergocalciferols Cholecalciferol Vitamins |
Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |