For critically ill adults, no mortality reduction with high-dose vitamin D

  • Ginde AA & al.
  • N Engl J Med
  • 26.12.2019

  • von Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • Although high-dose vitamin D supplementation quickly corrects deficiency in critically ill adults, it offers no mortality benefit.

Why this matters

  • Critically ill patients frequently have vitamin D deficiency.
  • VITdAL-ICU linked supplementation to lower mortality, but the trial was underpowered for that endpoint.

Key results

  • Trial was stopped early for futility.
  • Vitamin D vs placebo groups:
    • Mean day 3 level of 25-hydroxyvitamin D: 46.9±23.2 vs 11.4±5.6 ng/mL.
    • 90-day mortality: 23.5% vs 20.6% (P=.26).
    • No significant differences in secondary outcomes.
    • No deaths were thought to be caused by vitamin D or placebo.
  • Among vitamin D recipients, mortality was higher in those with infectious causes of illness and those with acute respiratory distress syndrome prior to randomization.

Study design

  • Multicenter, randomized, double-blind, placebo-controlled, phase 3 VIOLET trial (n=1078).
  • Participants were critically ill adults who had vitamin D deficiency and were deemed to have a high mortality risk. 
  • They were randomly assigned to early receipt of 1 enteral dose of 540,000 IU vitamin D vs placebo.
  • Outcomes: 90-day all-cause mortality.
  • Funding: NIH.

Limitations

  • Did not include patients in later stages of critical illness.