Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
NCT Number: NCT06736093
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with Vitamin D levels < 10 ng/ml Patients with Osteoporosis ( DEXA BMD T Score <-2.5)
Vitamin D3 60,000 IU given once weekly Pre Liver Transplant atleast for 6 weeks
Placebo capsules once weekly for atleast 6 weeks pre liver transplant
Time frame: 3 months post Liver Transplant
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Contact information is provided by the study sponsor or research team.
Nihar Mohapatra, MS, MCh
CONTACT
Sridhar L, MS
CONTACT
Institute of Liver and Biliary Sciences, India
Other
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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.