Table 5.

Comparison between the VITDALIZE and the VIOLET trial, the two ongoing, large vitamin D3 intervention trials in acute illness.

	VITHALIZE (Nbib3188796)	VIOLET (Nbib3096314)
Where	Europe, multicenter	US, multicenter
Design	Double-blind, placebo-controlled RCT	Double-blind, placebo-controlled RCT
Sample size	2400 (one interim analysis at 1200)	3000 (three interim analyses)
Intervention	Loading dose of 540,000 IU vitamin D3 (orally, enteral)Daily dose of 4000 IU vitamin D3 (orally, enteral) up to day 90	Single dose of 540,000 IU vitamin D3 (orally, enteral)
Inclusion criteria	25(OH)D <12 ng/mLAdmission to ICU (all-cause)	25(OH)D <20 ng/mL by point-of-care testAcute risk factors for ARDS and mortality contributing directly to the need for ICU admission
Primary endpoint	28-day-mortality (all-cause)	90-day-mortality (all-cause)
Recruitment started	October 2017	April 2017
Current status	Recruiting, estimated completion date 2021–2022	Stopped after first interim analysis (July 2018, ca 1400 patients)