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Study identifier: NCT03188796 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Critical Illness · Vitamin D Deficiency · Covid19  ·  Sponsor: Medical University of Graz

PhasePhase 3
Planned participants2400
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Karin Amrein, MD, MSc  ·  +43 681  ·  karin.amrein@medunigraz.at

Astrid Friedel  ·  +43 316 385  ·  astrid.friedel@medunigraz.at

Always discuss trial participation with your own doctor first.

Locations (18)

LKH EnzenbachEnzenbach, AustriaRecruiting
LKH FeldbachFeldbach, AustriaTerminated
Medical University of GrazGraz, AustriaRecruiting
Klinikum am WörtherseeKlagenfurt, AustriaRecruiting
LKH Hochsteiermark Standort LeobenLeoben, AustriaRecruiting
Barmherzige SchwesternLinz, AustriaRecruiting
Kepler Universitätsklinikum LinzLinz, AustriaRecruiting
Krankenhaus SchwarzachSchwarzach im Pongau, AustriaTerminated
Barmherzige BrüderVienna, AustriaRecruiting
Kaiser Franz Josef Spital WienVienna, AustriaSuspended
Medical University of ViennaVienna, AustriaRecruiting
LKH VillachVillach, AustriaRecruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03188796