# VITAL (VITamin D and OmegA-3 TriaL)

Source: https://onco.cc/trials/vital/  
OnCo record `vital` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The definitive test of whether vitamin D or fish-oil pills prevent cancer or heart disease in healthy adults. They did not.

## Summary

25,871 participants (including 5,106 Black participants) followed for a median 5.3 years. Vitamin D did not reduce invasive cancer incidence (793 vs 824 events, HR 0.96, 95% CI 0.88-1.06) or major cardiovascular events (HR 0.97); omega-3 did not reduce cancer (HR 1.03) or major cardiovascular events (HR 0.92), though it reduced myocardial infarction in secondary analysis. Total cancer mortality with vitamin D was HR 0.83 (0.67-1.02) overall and HR 0.75 (0.59-0.96) after excluding the first two years, a pre-specified but secondary analysis. Later ancillary analyses reported fewer advanced (metastatic or fatal) cancers with vitamin D, concentrated in normal-weight participants. The trial ended the hope of broad cancer prevention with supplements while leaving a testable mortality hypothesis.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-08
- Registry id: NCT01169259
- Phase: 3
- Setting: Primary prevention in US adults (men 50+, women 55+) without prior cancer or cardiovascular disease: vitamin D3 2000 IU/day and/or marine omega-3 1 g/day vs placebo, 2x2 factorial
- Sponsor: Brigham and Women's Hospital / NIH
- Enrolled: 25871
- Result: Invasive cancer incidence HR 0.96 (vitamin D), 1.03 (omega-3); no benefit on primary endpoints.
- Outcomes: Invasive cancer of any type: Vitamin D3 793 events vs Placebo 824 events, HR 0.96; Invasive cancer of any type: Omega-3 820 events vs Placebo 797 events, HR 1.03
- Replication: Consistent with D-Health (Australia, 21,315 participants, no reduction in mortality or cancer) and with meta-analyses showing no effect on incidence and a possible 10-15% reduction in cancer mortality.

## Sources

- ClinicalTrials.gov NCT01169259: https://clinicaltrials.gov/study/NCT01169259
- Vitamin D results (NEJM 2019): https://doi.org/10.1056/NEJMoa1809944
- Omega-3 results (NEJM 2019): https://doi.org/10.1056/NEJMoa1809946

## Connected records

- ideas: [A biomarker-directed trial of vitamin D after surgery for digestive tract cancers](https://onco.cc/ideas/idea-reg-vitamin-d-digestive-cancer-biomarker-trial/)
- fronts: [Diet, Exercise & Lifestyle](https://onco.cc/fronts/nutrition-lifestyle/), [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [Chemoprevention & risk-reducing surgery](https://onco.cc/technologies/chemoprevention/), [Vitamin D and omega-3 supplementation](https://onco.cc/technologies/vitamin-d-omega3-supplementation/)
- terms: [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/), [Unproven diet claims (alkaline, juice, 'anti-cancer' diets)](https://onco.cc/terms/unproven-diet-claims/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Misinformation and unproven therapies](https://onco.cc/bottlenecks/b-misinformation/)
- key papers: [Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease](https://onco.cc/key-papers/paper-manson-n-engl-j-med/)
- roadmaps: [Diet, exercise and lifestyle roadmap: causes established → interventions that disappointed → exercise proven as treatment](https://onco.cc/roadmaps/nutrition-lifestyle-roadmap/)

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