The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

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.

NCT Number	NCT03188796
Lead Sponsor	Medical University of Graz Collaborators: Medical University of Vienna, Hospital Barmherzige Brüder St. Veit, Klinikum Klagenfurt am Wörthersee, Johannes Kepler University of Linz, Krankenhaus Barmherzige Schwestern Linz, Barmherzige Brüder Vienna, Erasme University Hospital, The Queen Elizabeth Hospital, Goethe University, Kages, KABEG Management, Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Universitaire de Charleroi, Centre Hospitalier Universitaire Mons, Wuerzburg University Hospital, Royal Bolton Hospital NHS Foundation Trust, Heartlands Hospital, Royal Oldham Hospital, East Lancashire Hospitals NHS Trust, University of Plymouth, Royal Victoria Hospital, Belfast, Great Western Hospital, Mid Yorkshire Teaching NHS Trust, Musgrove Park Hospital, Scunthorpe General Hospital, Guy's and St Thomas' NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Hospital Barmherzige Brüder Graz, University Hospital Schleswig-Holstein, University Hospital, Bonn, Johannes Gutenberg University Mainz, University Hospital, Essen, Klinikum rechts der Isar der TUM, Landeskrankenhaus Villach
Conditions	Critical Illness, Vitamin D Deficiency, Covid19
Enrollment	2,400 participants
Start Date	2017-10-10
Primary Completion	2027-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-11-21