Clinical trial NCT06447441: Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
Official title: Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critically Ill
Sepsis
Mortality Rate
Critical Care
Keywords: Vitamin D
Cholecalciferol
Sepsis
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
First posted: 2024-06-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: Inclusion Criteria:

1. Medical subject ≥ 18 years old and diagnosed with sepsis
2. Transferred to the intensive care unit within 24 hours after being diagnosed with sepsis
3. Admitted to the ICU with 40 \> APACHE II score ≥ 15.
4. The intensivist anticipates that the subject will stay in the ICU ≥ 7 days.

Exclusion Criteria:

1. Diseases that affect serum levels of 25(OH)D and calcium, including thyroidectomy, parathyroid disease, rickets, or severe cirrhosis \[Child C\]
2. Received large doses of vitamin D3 in the past four weeks (\> 2000 IU per day or ≥ 10,000 IU in a single dose)
3. Admitted to the ICU with diagnosis of COVID-19
4. AIDS subjects taking immunosuppressants
5. Organ transplant
6. Active cancer
7. Tuberculosis, sarcoidosis, or kidney stones in the past one year
8. Weight \< 45 kg or \> 90 kg
9. Had been admitted to ICU in the past three months
10. Subject and family members who do not speak the native language
11. Pregnant women

Primary outcomes:
measure: 30-day Mortality
timeFrame: Up to 30 days after intervention
Secondary outcomes:
measure: ICU Length of Stay of Survivors
timeFrame: Up to 30 days after intervention
measure: iPTH concentration
timeFrame: 12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)
measure: calcifediol concentration ( 25(OH)D )
timeFrame: 12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)
Other outcomes:
Locations:
Study officials:
affiliation: Chimei Medical Center
name: Chin Ming Chen
role: PRINCIPAL_INVESTIGATOR
References: