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trialsTrialNegative

VITAL (VITamin D and OmegA-3 TriaL)

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

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.

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
Phase
Phase 3
Sponsor
Brigham and Women's Hospital / NIH
Registry
Headline result
Invasive cancer incidence HR 0.96 (vitamin D), 1.03 (omega-3); no benefit on primary endpoints.
Reported
2018
Enrolled
25871
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.

Outcomes

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In plain words
What these results mean for people, not percentages
25,871 people took part
Invasive cancer of any typeprimaryother endpoint
  • Vitamin D3: 793 events; Placebo: 824 events.
  • These are counts of events, not percentages, so compare them with the group sizes in mind.
  • Put another way, the treated group had about 4 percent lower chance of the event at any given time (hazard ratio 0.96, likely range 0.88 to 1.06).
Invasive cancer of any typeprimaryother endpoint
  • Omega-3: 820 events; Placebo: 797 events.
  • These are counts of events, not percentages, so compare them with the group sizes in mind.
  • Put another way, the treated group had about 3 percent higher chance of the event at any given time (hazard ratio 1.03, likely range 0.93 to 1.13).
Be careful
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
  • These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

25,871 participants enrolled.

Invasive cancer of any typeprimary
HR 0.96 (0.88–1.06) · p = 0.47
Vitamin D3
793 mo
Placebo
824 mo
Source
Invasive cancer of any typeprimary
HR 1.03 (0.93–1.13)
Omega-3
820 mo
Placebo
797 mo
Source
EndpointArmnValueHR (95% CI)pSource
Invasive cancer of any typeprimaryVitamin D312,927793 events0.96 (0.88–1.06)0.47link
Placebo12,944824 events
Invasive cancer of any typeprimaryOmega-312,933820 events1.03 (0.93–1.13)link
Placebo12,938797 events
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.

Connected

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not linked directly; found by shared links