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NCT Number: NCT06736093

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

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

Location status: Recruiting

Location contact

Sridhar L, MBBS MS

CONTACT

[email protected]

+91 9738387083

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D3

Drug

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

Placebo

Drug

Placebo capsules once weekly for atleast 6 weeks pre liver transplant

Primary outcomes

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

    Time frame: 3 months post Liver Transplant

Secondary outcomes

  1. To compare the Acute Graft Rejection rates between the two arms within 3 months post liver transplant

    Time frame: 3 months

  2. To compare the Sepsis (Bacterial and Fungal) and septic shock rate between the two arms within 3 months post liver transplant

    Time frame: 3 months

  3. To compare the Serum Vitamin D3 levels between the two arms at 3 months post liver transplant.

    Time frame: 3 months

  4. To compare the Bone mineral Density (T score) between the two arms at 3 months post liver transplant.

    Time frame: 3 months

  5. 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.

    Time frame: 3 months

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

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nihar Mohapatra, MS, MCh

CONTACT

[email protected]

+91-9910479799

Sridhar L, MS

CONTACT

[email protected]

+91-9738387083

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.