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

NCT06447441 | Not Yet Recruiting

• 1 other identifier: CMMC11302007
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critically Ill; Sepsis; Mortality Rate; Critical Care

Keywords

Vitamin D; Cholecalciferol; Sepsis

Outcome Measures

Primary Outcomes (1)

• 30-day Mortality

  Duration from the day of intervention to subjects died

  Up to 30 days after intervention

Secondary Outcomes (3)

• ICU Length of Stay of Survivors

  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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Enteral supplementation of placebo in 3 days

Other: Placebo

Vitamin D3 group

EXPERIMENTAL

Enteral supplementation of 1,728,000 IU vitamin D3 in 3 days

Other: Cholecalciferol

Interventions

Placebo OTHER

Enteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission.

Placebo

Cholecalciferol OTHER

Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission

Also known as: vitamin D3

Vitamin D3 group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Organ transplant
• Active cancer
• Tuberculosis, sarcoidosis, or kidney stones in the past one year
• Weight \< 45 kg or \> 90 kg
• Had been admitted to ICU in the past three months
• Subject and family members who do not speak the native language
• Pregnant women

Sponsors & Collaborators

• Chimei Medical Center: lead
• E-DA Hospital: collaborator

MeSH Terms

Conditions

Critical Illness; Sepsis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Chin Ming Chen

  Chimei Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin Ming Chen, professor

CONTACT

+886 6-2812811; Chencm3383@gmail.com

Jia Wei Lin

CONTACT

+886 6-62812811; lin959353@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share