Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis (MDC-S)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Critically Ill; Critical Care; Mortality Rate
• Intervention / Treatment: Other: Placebo; Other: Cholecalciferol

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin Ming Chen, professor; Phone Number: 56689 +886 6-2812811; Email: Chencm3383@gmail.com
• Study Contact Backup: Name: Jia Wei Lin; Phone Number: 52951 +886 6-62812811; Email: lin959353@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Enteral supplementation of placebo in 3 days	Other: Placebo; Enteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission.
Experimental: Vitamin D3 group; Enteral supplementation of 1,728,000 IU vitamin D3 in 3 days	Other: Cholecalciferol; Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission; Other Names: vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day Mortality	Duration from the day of intervention to subjects died	Up to 30 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Length of Stay of Survivors	Duration from the day of intervention to ICU discharge	Up to 30 days after intervention
iPTH concentration		12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)
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)

Collaborators and Investigators

• Sponsor: Chimei Medical Center
• Collaborators: E-DA Hospital
• Investigators: Principal Investigator: Chin Ming Chen, ChiMei Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D; Sepsis; Cholecalciferol
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Critical Illness; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CMMC11302007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No