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

September 29, 2019 updated by: Suk-Kyung, Asan Medical Center

The Clinical Effect of Preoperative Level of 25-OH-vitamin D3 on the Liver Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients received liver transplantation from June 2017 to November 2017

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who didn't have preoperative vitamin D level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Liver transplant patients with severe vitamin D deficiency (<10ng/ml)
2
Liver transplant patients with vitamin D insufficiency (10-20ng/ml)
3
Liver transplant patients with normal vitamin D status (>20ng/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay after liver transplant
Time Frame: 6 months
compared with each group
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of normalization of CRP, WBC
Time Frame: 6 months
compared with each group
6 months
Length of ICU stay
Time Frame: 6 months
compared with each group
6 months
New infection rate
Time Frame: 6 months
compared with each group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

November 30, 2017

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

September 29, 2019

First Submitted That Met QC Criteria

September 29, 2019

First Posted (ACTUAL)

October 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 29, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AsanMC-vitamin D

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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