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New treatment option for Critical Illness
Official title The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
ClinicalTrials.gov ID: NCT03188796
What this study is testing
What is Cholecalciferol?
Cholecalciferol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for critical illness.
Also referred to as Vitamin D3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- ≥18 years
- Anticipated ICU stay ≥ 48 hours
- Admission to ICU ≤ 72 hours before screening
- Severe vitamin D deficiency (≤12 ng/ml or undetectable)
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Enzenbach, Austria
- Feldbach, Austria
- Graz, Austria
- Klagenfurt, Austria
- Leoben, Austria
- Linz, Austria
- Schwarzach im Pongau, Austria
- Vienna, Austria
- Villach, Austria
- Brussels, Belgium
- Charleroi, Belgium
- Liège, Belgium
- Mons, Belgium
- Würzburg, Germany
- Birmingham, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Enzenbach, Austria; Feldbach, Austria; Graz, Austria; Klagenfurt, Austria; Leoben, Austria; Linz, Austria and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.