Relationship Between Serum Vitamin D and Outcomes of Liver Transplantation in Cirrhotic Patients Undergoing Liver Transplantation and Effects of Vitamin D Supplementation in Post-transplant Period

• Sponsor: National Nutrition and Food Technology Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05568836
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Anticipated Duration (Months): 12.3

Study Details

Study Description

Brief Summary

The study population is patients with liver cirrhosis undergoing liver transplantation; In this study, the sample will be selected from cirrhosis patients undergoing liver transplantation in Taleghani (Tehran), Imam Khomeini (Tehran) and Abu Ali Sina hospitals(Shiraz).

This study uses the recorded information of patients with cirrhosis who have undergone liver transplantation so far and have inclusion criteria and no exclusion criteria. First, we extract demographic and clinical and pathophysiological information of patients, including age, sex, BMI, cause of cirrhosis, medical status at the time of liver transplantation, history of abdominal surgery, portal vein thrombosis, and waiting time for liver transplantation. In the next step, we examine the serum level of vitamin D in different age and sex groups and determine the prevalence of vitamin D deficiency for each group. It should be noted that in this study, the serum level of 25-hydroxy vitamin D below 20 ng/mL will be considered an insufficient level.

In the next step, in patients 12 years of age and older, according to serum bilirubin, serum creatinine, serum sodium and INR, we calculate the MELD-Na score and evaluate it with the serum level of vitamin D or 25-hydroxy vitamin D. We also use PELD scores in patients younger than 12 years of age, which consist of age, serum albumin, total bilirubin, INR, and stunted growth.

Follow-up will be done by calling the patients and recruitment every 3 month. ACR or acute cell rejection is usually suspected after elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin (30). The incidence of ACR and Overall survival (OS) will be considered as the end point of the first phase of the study, and finally the incidence of 25-hydroxy vitamin D before transplantation with MELD-Na or PELD score will be examined. ACR and OS, we deal with statistical tests.

In the second phase of the study, which is a clinical trial, 50 sample patients with vitamin D deficiency will be selected from Taleghani Hospital; After transplanting, we will inject 300,000 units of vit D IM and compare their ACR and OS levels with those who have been deficient in vitamin D but whose vitamin D status has not improved. It is worth mentioning that in the second phase of the study, patients will be followed up to 3 months after liver transplantation.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications; Vitamin D Deficiency	Dietary Supplement: vitamin D supplementation; Other: control	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Relationship Between Serum Vitamin D and Outcomes of Liver Transplantation in Cirrhotic Patients Undergoing Liver Transplantation and Effects of Vitamin D Supplementation in Post-transplant Period
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention single dose of 300000 IU vitamin D injection (IM)	Dietary Supplement: vitamin D supplementation; Intervention group will receive a single IM injection of 300000 IU vitamin D
Other: Control No intervention	Other: control; control group will receive nothing

Outcome Measures

Primary Outcome Measures

1. ACR (acute cell rejection) [at the 3rd and 6th months after transplantation]

   elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin

Secondary Outcome Measures

1. MELD-Na or PELD score [at the 3rd and 6th months after transplantation]

2. Serum vitamin D [at the 3rd and 6th months after transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ESLD underwent liver transplantation

• Creatinine, bilirubin and INR measured

• Measured liver enzymes such as serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase / or bilirubin

Exclusion Criteria:

• People with acute liver failure

• People who have had multiple organ transplants

• Primary graft non-function (PNF) individuals

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Azita Hekmatdoost, Prof., National Nutrition and Food Technology Institute
• ClinicalTrials.gov Identifier: NCT05568836
• Other Study ID Numbers: 31748
• First Posted: Oct 6, 2022
• Last Update Posted: Oct 7, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dr Azita Hekmatdoost, Prof., National Nutrition and Food Technology Institute: vitamin D; liver transplantation
• Additional relevant MeSH terms: Vitamin D Deficiency; Vitamin D

Study Results

No Results Posted as of Oct 7, 2022