Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis

Sepsis Clinical Trial

— MDC-S  

Official title:

Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447441
• Other study ID #: CMMC11302007
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: June 2024
• Source: Chimei Medical Center
• Contact: Chin Ming Chen, professor
• Phone: +886 6-2812811
• Email: Chencm3383[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 31, 2029
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Critically Ill
• Mortality Rate
• Sepsis
• Toxemia

Intervention

Other:
• Placebo
Enteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission.
• Cholecalciferol
Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chimei Medical Center	E-DA Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day Mortality	Duration from the day of intervention to subjects died	Up to 30 days after intervention
Secondary	ICU Length of Stay of Survivors	Duration from the day of intervention to ICU discharge	Up to 30 days after intervention
Secondary	iPTH concentration		12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)
Secondary	calcifediol concentration ( 25(OH)D )		12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)