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
NCT ID: NCT05568836
Last Updated: 2022-10-07
Study Results
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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UNKNOWN
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2022-11-01
2023-11-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
single dose of 300000 IU vitamin D injection (IM)
vitamin D supplementation
Intervention group will receive a single IM injection of 300000 IU vitamin D
Control
No intervention
control
control group will receive nothing
Interventions
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vitamin D supplementation
Intervention group will receive a single IM injection of 300000 IU vitamin D
control
control group will receive nothing
Eligibility Criteria
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Inclusion Criteria
* Creatinine, bilirubin and INR measured
* Measured liver enzymes such as serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase / or bilirubin
Exclusion Criteria
* People who have had multiple organ transplants
* Primary graft non-function (PNF) individuals
ALL
No
Sponsors
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National Nutrition and Food Technology Institute
OTHER
Responsible Party
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Dr Azita Hekmatdoost
Prof.
Central Contacts
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Other Identifiers
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31748
Identifier Type: -
Identifier Source: org_study_id
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