The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients With Severe Vitamin D Deficiency: a Multicenter, Placebo-controlled Double-blind Phase III Randomized Controlled Trial (RCT)

VITDALIZE 1.0

In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, hazard ratio (HR) 0.52 (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of severely vitamin D deficient critically ill patients is a promising and inexpensive intervention that requires confirmatory multicenter studies. To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials. In case of benefit, vitamin D treatment in critically ill patients could be immediately implemented worldwide.

2017-10-10

2024-12-01

2025-03-01

Recruiting

Early phase I

2400

Inclusion Criteria: * ≥18 years * Anticipated ICU stay ≥ 48 hours * Admission to ICU ≤ 72 hours before screening * Severe vitamin D deficiency (≤12 ng/ml or undetectable) Exclusion Criteria: * Severe gastrointestinal dysfunction (\> 400 ml residual volume)/unable to take study medication * Do not resuscitate (DNR) order/imminent death * hypercalcemia * known recent nephrolithiasis, active tuberculosis or sarcoidosis * pregnancy/lactation * not deemed appropriate by study team/physician

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2024-05-17