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CTRI Number  CTRI/2024/12/077828 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Vitamin D on liver transplant recipients post surgery 
Scientific Title of Study   Effect of Preoperative Vitamin D Supplementation in Liver transplant recipients with Vitamin D deficiency on post transplant outcomes : A Randomised, double blind placebo-controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sridhar L 
Designation  Senior Resident 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  9738387083  
Fax    
Email  sridharlrao1993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nihar Mohapatra 
Designation  Assistant Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  9910479799  
Fax    
Email  nihar0310@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nihar Mohapatra 
Designation  Assistant Professor 
Affiliation  Institute of Liver and Biliary Sciences 
Address  Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  9910479799  
Fax    
Email  nihar0310@gmail.com  
 
Source of Monetary or Material Support  
ILBS,D-1,vasant kunj,new Delhi-110070. 
 
Primary Sponsor  
Name  ILBS, New Delhi 
Address  Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sridhar L  ILBS, New Delhi  Department of HPB Surgery and Liver Transplant, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi.
South West
DELHI 		 9738387083

sridharlrao1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj, New Delhi 110070  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo capsules once weekly for atleast 6 weeks pre liver transplant 
Intervention  Vitamin D Supplementation  Vitamin D3 60,000 IU given once weekly Pre Liver Transplant atleast for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients with Cirrhosis of Liver and Vitamin D deficiency ( defined as levels less than 30 ng per ml) undergoing Liver Transplant  
 
ExclusionCriteria 
Details  Negative consent
Pediatric patients
ALF
DDLT
Retransplant
Patients already receiving Vitamin D supplements.
K/C/O Hypo/ Hyperparathyroidism
H/o other Solid Organ Transplantation
Patients needing urgent Liver transplant before 6 weeks of Vitamin D Supplementation.
Patients with Vitamin D levels less than 10 ng per ml
Patients with Osteoporosis ( DEXA BMD T Score less than -2.5)
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Post Liver Transplant bacterial infection rates in the first 3 months between the two arms.  3 months post liver transplant 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Acute Graft Rejection rates between the two arms within 3 months post liver transplant.  3 months post liver transplant 
To compare the Sepsis (Bacterial and Fungal) and septic shock rate between the two arms within 3 months post liver transplant  3 months post liver transplant 
To compare the Serum Vitamin D3 levels and Bone mineral Density (T score) between the two arms at 3 months post liver transplant.  3 months post liver transplant 
To compare the Bone formation marker : osteocalcin (OC) and bone resorption marker : carboxyl-terminal telopeptide of type 1 collagen (CTX-1) between the two arms 3 months post liver transplant.  3 months post liver transplant 
To compare the Overall Survival between the two arms 3 months post liver transplant.  3 months post liver transplant 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Vitamin D deficiency is very common in these subsets of patients. Vitamin D is involved in calcium metabolism and bone mineralization, regulation of cytokines, immunomodulation, cellular proliferation and differentiation. Its deficiency can lead to immune dysregulation, and is associated with the development of viral and bacterial infections, cardiovascular and autoimmune diseases, and several types of cancer. To the best of our knowledge, there are no randomized studies which analyze the effect of Vitamin D supplementation preoperatively on post Liver Transplant outcomes. This double blinded placebo-controlled randomized study aims to analyze the effect of preoperative supplementation of Vitamin D in patients with Vitamin D deficiency on post liver transplant outcomes. All eligible adult patients with Chronic Liver Disease and Vitamin D deficiency undergoing Liver Transplant during the study period will be included in the study and randomized into two groups. One group will receive Oral Vitamin D3 - 60000 IU - once a week pre Liver Transplant for a minimum of 6 weeks and the other will receive placebo once a week for a minimum of 6 weeks in addition to 3 months Vitamin D supplementation post Liver Transplant in both arms.

 
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