The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Recruiting
Phase 3
Interventional Study
Critical Illness
Vitamin D Deficiency
Covid19
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,400 (estimated)
- Sponsor
- Medical University of Graz · Other
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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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* ≥18 years
* Anticipated ICU stay ≥ 48 hours
* Admission to ICU ≤ 72 hours before screening
* Severe vitamin D deficiency (≤12 ng/ml or undetectable)
Exclusion Criteria:
* Severe gastrointestinal dysfunction (\> 400 ml residual volume)/unable to take study medication
* Do not…
Contacts