Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorChimei Medical Center
About this trial
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 576,000 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 576,000 IU or placebo every 24 hours for 3 days (72 hours) within 96 hours after intensive care unit (ICU) admission.
Eligibility criteria
Qualifiers
Medical subject ≥ 18 years old and diagnosed with sepsis
Transferred to the intensive care unit within 24 hours after being diagnosed with sepsis
Admitted to the ICU with 40 > APACHE II score ≥ 15.
The intensivist anticipates that the subject will stay in the ICU ≥ 7 days.
Disqualifiers
Diseases that affect serum levels of 25(OH)D and calcium, including thyroidectomy, parathyroid disease, rickets, or severe cirrhosis [Child C]
Received large doses of vitamin D3 in the past four weeks (> 2000 IU per day or ≥ 10,000 IU in a single dose)
Admitted to the ICU with diagnosis of COVID-19
AIDS subjects taking immunosuppressants
Trial design
Treatments tested in this trial
- Placebo
- Cholecalciferol
Treatment groups
240 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Chimei Medical Center
Lead sponsor
E-DA Hospital
Collaborator
Source ClinicalTrials.gov