VITAL disappointment: vitamin D, omega-3s don't reduce CVD risk

  • N Engl J Med

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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  • Neither vitamin D at 2000 IU/day nor omega-3 supplementation reduced cardiovascular disease (CVD)-related event risk in the placebo-controlled VITAL trial.
  • Neither supplement affected invasive cancer incidence or reduced total cancer-related death rates.

Why this matters

  • These supplements du jour have reported potential to reduce these risks.
  • Results of this large randomized trial dampen the hype. 
  • Accompanying editorial notes pitfalls of secondary outcome findings.

Key results

  • Vitamin D:
    • In median 5.3-year follow-up, vs placebo, HR for major cardiac events was 0.97 (95% CI, 0.85-1.12; P=.69).
    • HR for invasive cancer also was not significant at 0.96 (95% CI, 0.88-1.06; P=.47).
    • No significant protection for most CVD or cancers separately, either.
  • Omega-3s:
    • With supplementation vs placebo, HR for CVD event was 0.92 (95% CI, 0.80-1.06; P=.24).
    • HR for invasive cancer was 1.03 (95% CI, 0.93-1.13; P=.56).
    • No significant protection for most CVD or cancers separately, either.

Study design

  • n=25,871 (n=5106 black participants) randomly allocated to vitamin D (2000 IU/day)/omega-3 (1 g/day fish-oil capsule with 840 mg of omega-3s), or placebo (2x2 design).
  • Nationwide US cohort, men ages 50 years or more, women 55 or older.
  • Endpoints: invasive cancer, composite of major cardiovascular events; secondary endpoints for specific CVDs, cancers.
  • Funding: NIH. 


  • Only 1 dose tested.
  • Short follow-up.
  • No corrections for multiple comparisons in secondary analyses.

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