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

Liver Transplant Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111146
• Other study ID #: AsanMC-vitamin D
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: June 30, 2019
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Disorder

Locations

Country	Name	City	State
Korea, Republic of	Hakjae Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Finkelmeier F, Kronenberger B, Köberle 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 — View Citation

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 201 — View Citation

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. — View Citation

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.in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital stay after liver transplant	compared with each group	6 months
Secondary	duration of normalization of CRP, WBC	compared with each group	6 months
Secondary	Length of ICU stay	compared with each group	6 months
Secondary	New infection rate	compared with each group	6 months