# The VITamin D and OmegA-3 TriaL (VITAL): Post-Intervention Follow-Up

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $850,000

## Abstract

ABSTRACT
This is a renewal application to extend post-intervention observational follow-up for 5 yrs in the VITamin D and
OmegA-3 TriaL (VITAL), a randomized, placebo-controlled factorial trial of daily vitamin D3 (2000 IU) and
marine omega-3 fatty acids (n-3 FAs; 1-g Omacor® fish-oil capsule, with eicosapentaenoic acid [460 mg] +
docosahexaenoic acid [380 mg]) in the primary prevention of cancer and cardiovascular disease (CVD) among
25,871 US men aged ≥50 and women aged ≥55 yrs, including 5,106 African Americans. Median treatment was
5.3 yrs. Funding for the ongoing 2-yr post-intervention follow-up (plus data closeout/analysis) ends on May 31,
2020. A 5-yr extension will yield a median post-intervention follow-up of 7 yrs and median cumulative
(intervention + post-intervention) follow-up of 12 yrs. During the trial, although vitamin D did not significantly
reduce total invasive cancer incidence in the overall cohort, there was a promising signal for a reduction in total
cancer mortality, and subgroup analyses indicated cancer protection in African Americans and those with
normal body mass index. Although n-3 FAs did not reduce major CVD events in the total cohort, there were
significant reductions in myocardial infarction (MI) and other coronary endpoints; subgroup analyses showed
reductions in major CVD events in those with low baseline fish intake and in MI in African Americans. Longer
follow-up to account for latency effects and additional research to learn which individuals may be most likely to
derive a net supplementation benefit is warranted. Annual surveys will update risk factors and endpoint
occurrence. Reported endpoints will be confirmed by medical record review and augmented with Medicare
linkage surveillance for maximal and unbiased endpoint capture. Deaths will be ascertained via the National
Death Index-Plus. Archived baseline blood/DNA samples will allow examination of whether effects of the trial
agents on cancer and CVD vary by (a) genetic factors (targeted variants in genes related to vitamin D
metabolism, absorption, or receptor function or n-3 FA synthesis and activation; gene-based ancestry; genetic
risk scores); (b) vitamin K and magnesium status; and (c) novel vitamin D and n-3 FA biomarkers. Moreover,
continued infrastructure funding will enhance the value of ongoing ancillary studies evaluating the trial agents’
role in prevention of other diseases (23 funded studies to date, including diabetes, cognitive decline, bone
disorders, and autoimmune conditions) and allow for future ones, including an examination of intervention
effects on tumor molecular markers, DNA methylation, and gene expression. Building upon VITAL’s
strengths—including a large, well-characterized, racially diverse cohort with high compliance throughout the
trial; archived blood samples; dietary and lifestyle assessments; and rigorously adjudicated endpoints—our
proposal offers an exceptionally innovative and cost-efficient (<$100/participant/yr in di...

## Key facts

- **NIH application ID:** 9970584
- **Project number:** 9R01AT011729-12
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Julie E. Buring
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $850,000
- **Award type:** 9
- **Project period:** 2009-09-29 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9970584

## Citation

> US National Institutes of Health, RePORTER application 9970584, The VITamin D and OmegA-3 TriaL (VITAL): Post-Intervention Follow-Up (9R01AT011729-12). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9970584. Licensed CC0.

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