Clinical trial NCT04111146: Effect of 25-OH-vitamin D3 on the Liver Transplant Recipients
Official title: The Clinical Effect of Preoperative Level of 25-OH-vitamin D3 on the Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant Disorder
Keywords: vitamin D
liver transplant
hospital stay
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients received liver transplantation from June 2017 to November 2017

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.

Eligibility 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

Primary outcomes:
measure: Hospital stay after liver transplant
timeFrame: 6 months
Secondary outcomes:
measure: duration of normalization of CRP, WBC
timeFrame: 6 months
measure: Length of ICU stay
timeFrame: 6 months
measure: New infection rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hakjae Lee
Study officials:
References:
citation: 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.
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 2015.
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.
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.intimp.2019.105811. Epub 2019 Aug 15.