Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03188796
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2017-06-13
Brief Title:
The VITDALIZE Study Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITDALIZE
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 25OHD 12ngml had significantly lower 28-day mortality 363 placebo vs 204 vitamin D group hazard ratio HR 052 030-089 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 eg 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
To date only 7 interventions eg 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
Detailed Description:
A very limited number of intervention trials most including less than 30 patients have been published The only phase III study our VITdAL-ICU study recruited from 2010 to 2012 and n475 did not find a difference in the primary endpoint length of hospital stay between placebo and high-dose vitamin D3 However there was a non-significant absolute risk reduction in all-cause hospital mortality in the total population The difference was larger 175 and significant in the predefined subgroup of patients with severe vitamin D deficiency at baseline see Kaplan Meier curve below n200 286 vs 461 p001 056 035-090 corresponding to a number needed to treat of 6 51 As this was only a secondary endpoint in the predefined subgroup with severe vitamin D deficiency this finding is hypothesis generating and requires further study leading to this application
In our study we were unable to identify a mechanism by which this benefit was achieved Interestingly looking at the causes of death the vitamin D group seemed to benefit in every category
The VITDALIZE study is a pragmatic multicenter placebo-controlled double-blind randomized controlled phase III trial in adult critically ill patients which will be conducted in academic and non-academic centers The sponsor is the Medical University of Graz Austria
Subjects will be randomised in a 11 ratio to receive either of the two treatments
Vitamin D oralenteral pharmacological dose of cholecalciferol vitamin D3
total dose 900000
loading dose of 5400000 dissolved in 375 ml of medium chain triglycerides - MCT followed by 4000 IU daily 10 drops for the entire active study period 90 days
Placebo identical regime - loading dose of 375 ml MCT followed by 10 drops daily
This study uses a group sequential design with one interim analysis when 50 of the planned enrolled patients in each arm N600 per arm have completed their day 28 assessment by the independent data safety monitoring board The enrollment of patients will continue while the interim analyses is performed
In our study we were unable to identify a mechanism by which this benefit was achieved Interestingly looking at the causes of death the vitamin D group seemed to benefit in every category
The VITDALIZE study is a pragmatic multicenter placebo-controlled double-blind randomized controlled phase III trial in adult critically ill patients which will be conducted in academic and non-academic centers The sponsor is the Medical University of Graz Austria
Subjects will be randomised in a 11 ratio to receive either of the two treatments
Vitamin D oralenteral pharmacological dose of cholecalciferol vitamin D3
total dose 900000
loading dose of 5400000 dissolved in 375 ml of medium chain triglycerides - MCT followed by 4000 IU daily 10 drops for the entire active study period 90 days
Placebo identical regime - loading dose of 375 ml MCT followed by 10 drops daily
This study uses a group sequential design with one interim analysis when 50 of the planned enrolled patients in each arm N600 per arm have completed their day 28 assessment by the independent data safety monitoring board The enrollment of patients will continue while the interim analyses is performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None