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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Critically Ill Sepsis Mortality Rate Critical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Enteral supplementation of placebo in 3 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Vitamin D3 group

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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type OTHER

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

Interventions

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Placebo

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

Intervention Type OTHER

Cholecalciferol

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

Intervention Type OTHER

Other Intervention Names

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vitamin D3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No