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

NCT06736093 | Recruiting

• 1 other identifier: ILBS-CLDVitaminD-2024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Liver Transplant Infection

Outcome Measures

Primary Outcomes (1)

• To compare the Post Liver Transplant bacterial infection rates in the first 3 months between the two arms.

  3 months post Liver Transplant

Secondary Outcomes (6)

• 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 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

Study Arms (2)

Vitamin D Supplementation Arm

ACTIVE COMPARATOR

Drug: Vitamin D3

Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Vitamin D3 DRUG

Vitamin D3 60,000 IU given once weekly Pre Liver Transplant atleast for 6 weeks

Vitamin D Supplementation Arm

Placebo DRUG

Placebo capsules once weekly for atleast 6 weeks pre liver transplant

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nihar Mohapatra, MS, MCh

  Institute of Liver and Biliary Sciences, New Delhi, India

  STUDY DIRECTOR

• Sridhar L, MS

  Institute of Liver and Biliary Sciences, New Delhi, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sridhar L, MS

CONTACT

+91-9738387083; sridharlrao1993@gmail.com

Nihar Mohapatra, MS, MCh

CONTACT

+91-9910479799; nihar0310@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 16, 2024
• Study Start: January 10, 2025
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)