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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Liver Transplant Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D Supplementation Arm

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

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

Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules once weekly for atleast 6 weeks pre liver transplant

Interventions

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Vitamin D3

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

Intervention Type DRUG

Placebo

Placebo capsules once weekly for atleast 6 weeks pre liver transplant

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No