Viewing Study NCT06447441



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06447441
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-17
First Post: 2024-06-03

Brief Title: Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
Sponsor: Chimei Medical Center
Organization: Chimei Medical Center

Study Overview

Official Title: Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
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: MDC-S
Brief Summary: Non-COVID-19 sepsis Sepsis has always been one of the common diseases in critically ill patients The main treatment strategy is to kill pathogens and mitigate hyperinflammation One study demonstrated that the supplementation with 576000 IU cholecalciferol vitamin D3 as a single dose in critically ill adults in the medical intensive care units MICUs can improve clinical outcomes including acute physiology and chronic health evaluation II score APACHE II sequential organ failure assessment score SOFA and C-reactive protein CRP

It is a three-year multi-center prospective parallel double-blind randomized controlled clinical trial for 240 eligible subjects with administrations of vitamin D3 576000 IU or placebo every 24 hours for 3 days 72 hours within 96 hours after intensive care unit ICU admission
Detailed Description: None

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