Effect of Preoperative Vitamin D Supplementation in Liver Transplant Recipients With Vitamin D Deficiency on Post Transplant Outcomes

Not Applicable

Not yet recruiting

• Conditions: Post Liver Transplant Infection
• Interventions: Drug: Vitamin D3; Drug: Placebo

• Registration Number: NCT06736093
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study Start: 2024-12-15
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• All adult patients >18 yrs with Cirrhosis of Liver and Vitamin D deficiency ( defined as levels < 30 ng/ml) undergoing Liver Transplant.

Exclusion Criteria

• Negative consent Pediatric patients Infection at the time of Liver Transplant Acute Liver Failure Deceased Donor Liver Transplant Patients undergoing Re Liver Transplant Patients already receiving Vitamin D supplements. Patients with Hypoparathyroidism/ Hyperparathyroidism H/o other Solid Organ Transplantation Patients needing urgent Liver transplant before 6 weeks of Vitamin D Supplementation.

Patients with Vitamin D levels < 10 ng/ml Patients with Osteoporosis ( DEXA BMD T Score <-2.5)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D Supplementation Arm	Vitamin D3	-
Placebo Arm	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To compare the Acute Graft Rejection rates between the two arms within 3 months post liver transplant	3 months
To compare the Sepsis (Bacterial and Fungal) and septic shock rate between the two arms within 3 months post liver transplant	3 months
To compare the Serum Vitamin D3 levels between the two arms at 3 months post liver transplant.	3 months
To compare the Bone mineral Density (T score) between the two arms at 3 months post liver transplant.	3 months
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
To compare the Overall Survival between the two arms 3 months post liver transplant.	3 months