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
Primary Purpose
Liver Transplant; Complications, Vitamin D Deficiency
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
vitamin D supplementation
control
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplant; Complications focused on measuring vitamin D, liver transplantation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Intervention
Control
Arm Description
single dose of 300000 IU vitamin D injection (IM)
No intervention
Outcomes
Primary Outcome Measures
ACR (acute cell rejection)
elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin
Secondary Outcome Measures
MELD-Na or PELD score
Serum vitamin D
Full Information
NCT ID
NCT05568836
First Posted
October 3, 2022
Last Updated
October 5, 2022
Sponsor
National Nutrition and Food Technology Institute
1. Study Identification
Unique Protocol Identification Number
NCT05568836
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant; Complications, Vitamin D Deficiency
Keywords
vitamin D, liver transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
single dose of 300000 IU vitamin D injection (IM)
Arm Title
Control
Arm Type
Other
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D supplementation
Intervention Description
Intervention group will receive a single IM injection of 300000 IU vitamin D
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
control group will receive nothing
Primary Outcome Measure Information:
Title
ACR (acute cell rejection)
Description
elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin
Time Frame
at the 3rd and 6th months after transplantation
Secondary Outcome Measure Information:
Title
MELD-Na or PELD score
Time Frame
at the 3rd and 6th months after transplantation
Title
Serum vitamin D
Time Frame
at the 3rd and 6th months after transplantation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azita Hekmatdoost, MD, PhD
Phone
+98-22376470
Email
a_hekmat2000@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
We'll reach out to this number within 24 hrs