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.
References
References
