Actively Recruiting
Effect of Preoperative Vitamin D Supplementation in Liver Transplant Recipients With Vitamin D Deficiency on Post Transplant Outcomes
Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-06-27
140
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. All Liver Transplant Recipients with Vitamin D deficiency will be screened in the pre-operative period in the outpatient department. Pre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 3 months after the Liver Transplant and the post transplant bacterial infection rates will be compared between the two groups along with other parameters.
CONDITIONS
Official Title
Effect of Preoperative Vitamin D Supplementation in Liver Transplant Recipients With Vitamin D Deficiency on Post Transplant Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years with liver cirrhosis and Vitamin D deficiency (levels below 30 ng/ml) scheduled for liver transplant
You will not qualify if you...
- Refusal to consent
- Pediatric patients
- Infection at the time of liver transplant
- Acute liver failure
- Deceased donor liver transplant
- Patients undergoing repeat liver transplant
- Patients already taking Vitamin D supplements
- Patients with hypoparathyroidism or hyperparathyroidism
- History of other solid organ transplantation
- Patients needing urgent liver transplant before completing 6 weeks of Vitamin D supplementation
- Vitamin D levels below 10 ng/ml
- Osteoporosis with DEXA BMD T Score below -2.5
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
S
Sridhar L, MS
CONTACT
N
Nihar Mohapatra, MS, MCh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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