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.
Conditions
Interventions
Trade Name: UVEDOSE
Product Name: NA
Product Code: NA
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Sponsors
CHU of Pointe-A-Pitre
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Contacts
Public ContactCRA
CHU of Pointe-A-Pitre
Outcome results
None listed