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

NCT ID: NCT04111146

Last Updated: 2019-10-01

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

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Liver Transplant Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Liver transplant patients with severe vitamin D deficiency (\<10ng/ml)

No interventions assigned to this group

2

Liver transplant patients with vitamin D insufficiency (10-20ng/ml)

No interventions assigned to this group

3

Liver transplant patients with normal vitamin D status (\>20ng/ml)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Suk-Kyung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hakjae Lee

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Finkelmeier F, Kronenberger B, Koberle V, Bojunga J, Zeuzem S, Trojan J, Piiper A, Waidmann O. Severe 25-hydroxyvitamin D deficiency identifies a poor prognosis in patients with hepatocellular carcinoma - a prospective cohort study. Aliment Pharmacol Ther. 2014 May;39(10):1204-12. doi: 10.1111/apt.12731. Epub 2014 Mar 29.

Reference Type RESULT
PMID: 24684435 (View on PubMed)

Finkelmeier F, Kronenberger B, Zeuzem S, Piiper A, Waidmann O. Low 25-Hydroxyvitamin D Levels Are Associated with Infections and Mortality in Patients with Cirrhosis. PLoS One. 2015 Jun 29;10(6):e0132119. doi: 10.1371/journal.pone.0132119. eCollection 2015.

Reference Type RESULT
PMID: 26121590 (View on PubMed)

Grant C. A vitamin D protocol post-liver transplantation. J Am Assoc Nurse Pract. 2017 Nov;29(11):658-666. doi: 10.1002/2327-6924.12503. Epub 2017 Aug 25.

Reference Type RESULT
PMID: 28840965 (View on PubMed)

Zhou Q, Li L, Chen Y, Zhang J, Zhong L, Peng Z, Xing T. Vitamin D supplementation could reduce the risk of acute cellular rejection and infection in vitamin D deficient liver allograft recipients. Int Immunopharmacol. 2019 Oct;75:105811. doi: 10.1016/j.intimp.2019.105811. Epub 2019 Aug 15.

Reference Type RESULT
PMID: 31422183 (View on PubMed)

Other Identifiers

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AsanMC-vitamin D

Identifier Type: -

Identifier Source: org_study_id

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