The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Medical University of Graz
Collaborators:
Barmherzige Brüder Vienna Centre Hospitalier Régional de la Citadelle Centre Hospitalier Universitaire de Charleroi Centre Hospitalier Universitaire Mons Erasme University Hospital Hospital Barmherzige Brüder St. Veit Johannes Kepler University of Linz KABEG Management Kages Klinikum Klagenfurt am Wörthersee Krankenhaus Barmherzige Schwestern Linz Medical University Innsbruck Medical University of Vienna University Hospital, Frankfurt University of Birmingham Wuerzburg University Hospital
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins