# The VITAL Rhythm Study

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $494,109

## Abstract

Atrial fibrillation (AF) remains the most common heart rhythm disturbance and the prevalence continues to
grow exponentially. It is currently estimated that 33.5 million people worldwide are afflicted with AF. Once
established, AF is associated with significant morbidity and mortality, much of which is not impacted by current
treatment options. In this competing continuation of the VITAL Rhythm Study, we propose to continue our
evaluation of the balance of benefits and risks of marine omega-3 fatty acid (840 mg eicosapentaenoic acid
[EPA] + docosahexaenoic acid [DHA]) and vitamin D3 (2,000 IU/day cholecalciferol) on AF incidence in the
setting of an NIH-funded large-scale clinical trial, the VITamin D and OmegA-3 TriaL (VITAL). VITAL is an
ongoing, randomized, double-blind, placebo-controlled, 2x2 factorial trial specifically designed to evaluate the
efficacy of vitamin D3 and marine omega-3 fatty acid supplements in the primary prevention of cancer and
cardiovascular disease among 25,874 men (aged 50+ years) and women (aged 55+ years). Benefits and risks
with respect to incident AF have been postulated for both of these commonly used supplements based on
results from observational studies and short-term secondary prevention randomized trials, but definitive data
from a large-scale primary prevention randomized trial are lacking. In this competing continuation, we propose
to continue our ancillary study that is in the process of ascertaining and adjudicating AF outcomes within the
VITAL trial to test whether long-term treatment (5-years) with omega-3 fatty acid and/or vitamin D3
supplementation has an impact on the incidence AF over 7-years of follow-up in an older population. Case
validation of incident AF is ongoing and involves systematic ascertainment of physician diagnoses of AF on
annual study questionnaires supplemented by CMS linkage followed by collection of detailed diagnostic
information from medical records. The extended follow-up will allow us to fully ascertain and adjudicate the AF
endpoints occurring throughout the 5 year VITAL randomized trial and a 2-year post-intervention period and
determine whether these agents might have a selective impact on persistent versus paroxysmal forms of AF.
Since both agents are known to impact biologic processes involved in atrial structural and electrical
remodeling, long-term post-intervention benefits and/or selective benefits on persistent forms of AF are
plausible. The additional endpoints that will be adjudicated during the continuation along with the separately
funded measurements of plasma 25(OH)D and EPA+DHA assays in the VITAL trial will also allow us to
perform important sub-analyses according to sex and baseline nutrient level. In summary, we propose to build
on the infrastructure and processes created in the first funding cycle and continue to take advantage of the
enormous investment of resources and infrastructure in the VITAL trial to provide a definitive and full
assessment of the...

## Key facts

- **NIH application ID:** 9980456
- **Project number:** 5R01HL116690-07
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** CHRISTINE M ALBERT
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $494,109
- **Award type:** 5
- **Project period:** 2013-07-09 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980456

## Citation

> US National Institutes of Health, RePORTER application 9980456, The VITAL Rhythm Study (5R01HL116690-07). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9980456. Licensed CC0.

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