Impact of high dose of vitamin D in critically ill septic patients with vitamin D deficiency: the CaribDean study
Phase 1
- Conditions
- Morbi-mortality in critically ill patients is linked to vitamin D deficiency. Moreover, vitamin D deficiency has been related to inappropriate response to infection (due to vitamin D involvement in immunity signaling pathways, including response to pathogens). Recent data about critically ill patients suggest that the lowest range of vitamin D status seems to benefit from cholecalciferol supplementation.Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2017-002355-28-FR
- Lead Sponsor
- CHU of Pointe-A-Pitre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2200
Inclusion Criteria
Patients hospitalized in ICU for sepsis who are more than 18 years old, insured under a French social security system, with a ?SOFA=2, 25(OH)D<20 ng/mL are eligible for study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
Exclusion Criteria
Pregnant or breastfeeding women; hypercalcemia, tuberculosis; sarcoidosis; nephrolithiasis within the prior year, and patients not deemed suitable for study participation (i.e., psychiatric disease, living remotely from the clinic, or prisoner status).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Impact of survival rate at D30;Secondary Objective: Impact of survival rate at D90, ?SOFA, vasopressor-free days at D30 , intensive care unit-free days, antibiotics-free days, ventilation-free days, ventilatory acquired pneumoniae, catheter related infection, bacteremia, composite endpoint including.;Primary end point(s): Survival rate at D30;Timepoint(s) of evaluation of this end point: End of study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Survival rate at D90, ?SOFA, vasopressor-free days at D30 , intensive care unit-free days, antibiotics-free days, ventilation-free days, ventilatory acquired pneumoniae, catheter related infection, bacteremia, composite endpoint including [death, ventilatory acquired pneumonia, catheter infection, bacteremia];Timepoint(s) of evaluation of this end point: End of study