Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04915963
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2021-06-01
Brief Title:
Vitamin D Supplementation in Intensive Care Unit Patients
Sponsor:
Association Tunisienne dEtude de Recherche sur lAthérosclérose
Organization:
Association Tunisienne dEtude de Recherche sur lAthérosclérose
Study Overview
Official Title:
Effect of a Single Mega-dose of Vitamin D3 Supplementation on Clinical Course in Non-deficient Patients Admitted in Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2021-06
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:
None
Brief Summary:
A randomized controlled trial is designed to investigate the safety and clinical efficacy of a mega dose of VD in patients admitted in intensive care unit ICU Patients will be randomly allocated to receive 400000 IU of VD3 or placebo They will be followed up until ICU discharge or death or the 15th day of ICU stay Adverse events that occur during ICU stay is collected Primary outcome is intensive care unit-acquired infection ICU-AI and secondary outcomes are septic shock organ failure and ICU-mortality Plasma 25-hydroxyvitamin D is assessed at baseline and at the end of follow-up Cox regression models will be applied to test how VD supplementation affects adverse outcomes while adjusting for confounders
Detailed Description:
The randomized controlled trial aimed to investigate the safety and clinical efficacy of a single mega dose of vitamin D VD in patients admitted at intensive care unit ICU
Study participants VD deficient ICU patients
Criteria of inclusion patients
newly admitted within 24 hours
over eighteen
able to receive medication orally or through nasogastric tube
expected to stay more than 72 hours in ICU
Criteria for non-inclusion and exclusion patients
lack of patients or relatives consent
expected short life or ICU stay 48 hours
sepsis at admission
kidney liver or intestinal disease
hypercalcemia total calcium106 mgdL
history of a disorder associated with hypercalcemia cancer tuberculosis sarcoidosis hyperparathyroidism nephrolithiasis
treatment with immunotherapy or vitamin supplements within one year
pregnant or breastfeeding women
discharge from ICU or death within 72 hours of admission
Study protocol
Patients will undergo physical examination with calculation of acute physiology and chronic assessment II APACHE II and sequential organ failure assessment SOFA scores They will be randomly assigned to either VD or placebo group after stratification on gender age and APACHE II
VD group 170 patients will receive a single dose of 400000 IU of VD3 orally or through nasogastric tube
Placebo group 170 patients will receive distilled water orally or through nasogastric tube
The patients will followed up until ICU discharge or death or the 15th day of ICU stay whichever occurs first and adverse events that occurred during ICU stay were collected
Primary outcome intensive care unit-acquired infection ICU-AI defined as an infection of blood stream lower respiratory tract urinary tract skinsoft tissue or gastrointestinal tract which was not present within the first 48 hours of admission into the ICU
Secondary outcomes urinary calciumcreatinine ratio as surrogate for VD toxicity septic shock organ failure ICU-mortality
Plasma 25-hydroxyvitamin D 25-OHD will be assessed at baseline and the end of follow-up using immunoassay
Cox regression models will be applied to test how VD supplementation affects adverse events and ICU-mortality while adjusting for confounders
Hypothesis Recovering an adequate VD status might reduce poor outcome especially infectious outcomes in ICU patients
Study participants VD deficient ICU patients
Criteria of inclusion patients
newly admitted within 24 hours
over eighteen
able to receive medication orally or through nasogastric tube
expected to stay more than 72 hours in ICU
Criteria for non-inclusion and exclusion patients
lack of patients or relatives consent
expected short life or ICU stay 48 hours
sepsis at admission
kidney liver or intestinal disease
hypercalcemia total calcium106 mgdL
history of a disorder associated with hypercalcemia cancer tuberculosis sarcoidosis hyperparathyroidism nephrolithiasis
treatment with immunotherapy or vitamin supplements within one year
pregnant or breastfeeding women
discharge from ICU or death within 72 hours of admission
Study protocol
Patients will undergo physical examination with calculation of acute physiology and chronic assessment II APACHE II and sequential organ failure assessment SOFA scores They will be randomly assigned to either VD or placebo group after stratification on gender age and APACHE II
VD group 170 patients will receive a single dose of 400000 IU of VD3 orally or through nasogastric tube
Placebo group 170 patients will receive distilled water orally or through nasogastric tube
The patients will followed up until ICU discharge or death or the 15th day of ICU stay whichever occurs first and adverse events that occurred during ICU stay were collected
Primary outcome intensive care unit-acquired infection ICU-AI defined as an infection of blood stream lower respiratory tract urinary tract skinsoft tissue or gastrointestinal tract which was not present within the first 48 hours of admission into the ICU
Secondary outcomes urinary calciumcreatinine ratio as surrogate for VD toxicity septic shock organ failure ICU-mortality
Plasma 25-hydroxyvitamin D 25-OHD will be assessed at baseline and the end of follow-up using immunoassay
Cox regression models will be applied to test how VD supplementation affects adverse events and ICU-mortality while adjusting for confounders
Hypothesis Recovering an adequate VD status might reduce poor outcome especially infectious outcomes in ICU patients
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?:
False
Is an FDA AA801 Violation?:
None