NCT06736093 Effect of Preoperative Vitamin D Supplementation in Liver Transplant Recipients With Vitamin D Deficiency on Post Transplant Outcomes
| NCT ID | NCT06736093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Post Liver Transplant Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-01-10 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Nihar Mohapatra, MS, MCh
STUDY DIRECTOR
Institute of Liver and Biliary Sciences, New Delhi, India
Frequently Asked Questions
Who can join the NCT06736093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Liver Transplant Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06736093 currently recruiting?
Yes, NCT06736093 is actively recruiting participants. Contact the research team at sridharlrao1993@gmail.com for enrollment information.
Where is the NCT06736093 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT06736093 clinical trial?
NCT06736093 is sponsored by Institute of Liver and Biliary Sciences, India. The principal investigator is Nihar Mohapatra, MS, MCh at Institute of Liver and Biliary Sciences, New Delhi, India. The trial plans to enroll 140 participants.