NCT03188796 The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
| NCT ID | NCT03188796 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Medical University of Graz |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2017-10-10 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,400 participants in total. It began in 2017-10-10 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 resuscitate (DNR) order/imminent death * hypercalcemia * known recent nephrolithiasis, active tuberculosis or sarcoidosis * pregnancy/lactation * not deemed appropriate by study team/physician
Contact & Investigator
Karin Amrein, MD, MSc
PRINCIPAL INVESTIGATOR
Medical University of Graz
Frequently Asked Questions
Who can join the NCT03188796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03188796 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,400 participants.
Is NCT03188796 currently recruiting?
Yes, NCT03188796 is actively recruiting participants. Contact the research team at karin.amrein@medunigraz.at for enrollment information.
Where is the NCT03188796 trial being conducted?
This trial is being conducted at Enzenbach, Austria, Feldbach, Austria, Graz, Austria, Klagenfurt, Austria and 11 additional locations.
Who is sponsoring the NCT03188796 clinical trial?
NCT03188796 is sponsored by Medical University of Graz. The principal investigator is Karin Amrein, MD, MSc at Medical University of Graz. The trial plans to enroll 2,400 participants.