CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 2,400 target
Drug / intervention
Cholecalciferol +1 moredrug
Likely dose
Cholecalciferol 37.5 mlfrom record
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Anticipated ICU stay of at least 48 hours
  • ✓ICU admission within 72 hours before screening
  • ✓Severe vitamin D deficiency (≤12 ng/ml or undetectable)
Key exclusion· 6
  • ✕Severe gastrointestinal dysfunction with >400 ml residual volume or unable to take study medication
  • ✕Do not resuscitate order or imminent death
  • ✕Hypercalcemia
  • ✕Recent nephrolithiasis, active tuberculosis, or sarcoidosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03188796
NCT03188796Phase 3RecruitingOn TrackUpdated 7mo ago
Long Recruiting
CompareCT.gov

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)

Medical University of Graz·interventional·Posted Jun 15, 2017·Updated Nov 21, 2025

In Brief

A Phase 3 clinical trial evaluating Cholecalciferol and Placebo for Critical Illness and 2 related conditions. Currently recruiting, targeting 2,400 participants across 18 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Illness, Vitamin D Deficiency, Covid19
CountriesAustria, Belgium, Germany, United Kingdom
CollaboratorsMedical 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

Timeline

Phase 3Recruiting
2018201920202021202220232024202520262027
First PostedJun 15, 2017
Enrollment StartOct 10, 2017
Primary CompletionMar 1, 2027
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 9.0 years agoPrimary completion in 8 months

Interventions

Cholecalciferoldrug

oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days

Placebodrug

oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days