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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06736093

Enrollment

140

Registered

2024-12-16

Start date

2024-12-30

Completion date

2026-07-13

Last updated

2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Liver Transplant Infection

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.

Interventions

DRUGVitamin D3

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

DRUGPlacebo

Placebo capsules once weekly for atleast 6 weeks pre liver transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

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 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
To compare the Overall Survival between the two arms 3 months post liver transplant.	3 months

Countries

India

Contacts

STUDY_DIRECTORNihar Mohapatra, MS, MCh

Institute of Liver and Biliary Sciences, New Delhi, India

PRINCIPAL_INVESTIGATORSridhar L, MS