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NOT YET RECRUITING
NCT06447441
NA

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

Sponsor: Chimei Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-07-01

Completion Date

2029-12-31

Last Updated

2024-06-17

Healthy Volunteers

No

Interventions

OTHER

Placebo

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

OTHER

Cholecalciferol

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