The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
Qualifiers
≥18 years
Anticipated ICU stay ≥ 48 hours
Admission to ICU ≤ 72 hours before screening
Severe vitamin D deficiency (≤12 ng/ml or undetectable)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cholecalciferol
- Placebo
Treatment groups
2,400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of Graz
Lead sponsor
Medical University of Vienna
Collaborator
Hospital Barmherzige Brüder St. Veit
Collaborator
Klinikum Klagenfurt am Wörthersee
Collaborator
Johannes Kepler University of Linz
Collaborator
Krankenhaus Barmherzige Schwestern Linz
Collaborator
Barmherzige Brüder Vienna
Collaborator
Erasme University Hospital
Collaborator
The Queen Elizabeth Hospital
Collaborator
Goethe University
Collaborator
Kages
Collaborator
KABEG Management
Collaborator
Centre Hospitalier Régional de la Citadelle
Collaborator
Centre Hospitalier Universitaire de Charleroi
Collaborator
Centre Hospitalier Universitaire Mons
Collaborator
Wuerzburg University Hospital
Collaborator
Royal Bolton Hospital NHS Foundation Trust
Collaborator
Heartlands Hospital
Collaborator
Royal Oldham Hospital
Collaborator
East Lancashire Hospitals NHS Trust
Collaborator
University of Plymouth
Collaborator
Royal Victoria Hospital, Belfast
Collaborator
Great Western Hospital
Collaborator
Mid Yorkshire Teaching NHS Trust
Collaborator
Musgrove Park Hospital
Collaborator
Scunthorpe General Hospital
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
Hospital Barmherzige Brüder Graz
Collaborator
University Hospital Schleswig-Holstein
Collaborator
University Hospital, Bonn
Collaborator
Johannes Gutenberg University Mainz
Collaborator
University Hospital, Essen
Collaborator
Klinikum rechts der Isar der TUM
Collaborator
Landeskrankenhaus Villach
Collaborator
Source ClinicalTrials.gov