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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Liver Transplant Infection
• Intervention / Treatment: Drug: Vitamin D3; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sridhar L, MS; Phone Number: +91-9738387083; Email: sridharlrao1993@gmail.com
• Study Contact Backup: Name: Nihar Mohapatra, MS, MCh; Phone Number: +91-9910479799; Email: nihar0310@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver and Biliary Sciences
      • Contact: Sridhar L, MBBS MS; Phone Number: +91 9738387083; Email: sridharlrao1993@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm	Drug: Placebo; Placebo capsules once weekly for atleast 6 weeks pre liver transplant
Active Comparator: Vitamin D Supplementation Arm	Drug: Vitamin D3; Vitamin D3 60,000 IU given once weekly Pre Liver Transplant atleast for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 Overall Survival between the two arms 3 months post liver transplant.	3 months
To compare Bone formation markers-Osteocalcin (OC),Osteoprotegerin (OPG) and bone resorption markers -carboxyl-terminal telopeptide of type 1 collagen (CTX-1), Bone-specific Alkaline Phosphatase (BALP) between the two arms 3 months post liver transplant.	3 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Nihar Mohapatra, MS, MCh, Institute of Liver and Biliary Sciences, New Delhi, India; Principal Investigator: Sridhar L, MS, Institute of Liver and Biliary Sciences, New Delhi, India

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Cholecalciferol
• Other Study ID Numbers: ILBS-CLDVitaminD-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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