Effect of 25-OH-vitamin D3 on the Liver Transplant Recipients

Completed

• Conditions: Liver Transplant Disorder

• Registration Number: NCT04111146
• Lead Sponsor: Asan Medical Center

Brief Summary

The low vitamin D3 levels and malnutrition before liver transplantation showed an increase in the length of stay in ICU and hospital. Although several factors may influence the clinical outcomes of patients with liver transplantation, low vitamin D3 levels showed an independent risk factor. It is necessary to prospectively analyze the effect of vitamin D supplements on clinical outcomes in liver transplant recipients.

Detailed Description

Purpose: Vitamin D deficiency is common in patients of chronic liver disease and has been associated with infection and mortality. The aim of this study is to determine whether preoperative vitamin D levels affect clinical outcomes after liver transplantation.

Methods : This was a single-center retrospective study. Between June and November 2017, a total of 219 patients underwent liver transplantation. The primary outcome was the relationship between serum 25-OH-vitamin D3 level before liver transplantation and length of stay in the intensive care unit (ICU). Secondary outcomes included the duration of normalization of inflammatory marker, such as white blood cell count (WBC) \& C-reactive protein (CRP) after liver transplantation, new infection rates, rejection rates, the length of hospital stay and mortality among vitamin D level.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-11-30
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-09-29
• Last Update Submitted: 2019-09-29
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• The patients who admitted to intensive care unit (ICU) after liver transplantation were studied

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Exclusion Criteria

• Patients who didn't have preoperative vitamin D level

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital stay after liver transplant	6 months	compared with each group

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	6 months	compared with each group
duration of normalization of CRP, WBC	6 months	compared with each group
New infection rate	6 months	compared with each group

Trial Locations

Locations (1)

Hakjae Lee; 🇰🇷 Seoul, Korea, Republic of