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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111146
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Suk-Kyung, 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.

Condition or disease
Liver Transplant Disorder

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.

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Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Clinical Effect of Preoperative Level of 25-OH-vitamin D3 on the Liver Transplant Recipients
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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)



Primary Outcome Measures :
  1. Hospital stay after liver transplant [ Time Frame: 6 months ]
    compared with each group


Secondary Outcome Measures :
  1. duration of normalization of CRP, WBC [ Time Frame: 6 months ]
    compared with each group

  2. Length of ICU stay [ Time Frame: 6 months ]
    compared with each group

  3. New infection rate [ Time Frame: 6 months ]
    compared with each group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients received liver transplantation from June 2017 to November 2017
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111146


Locations
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Korea, Republic of
Hakjae Lee
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Publications of Results:
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Responsible Party: Suk-Kyung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04111146    
Other Study ID Numbers: AsanMC-vitamin D
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suk-Kyung, Asan Medical Center:
vitamin D
liver transplant
hospital stay