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Effect of Vitamin D on liver transplant recipients post surgery

Effect of Preoperative Vitamin D Supplementation in Liver transplant recipients with Vitamin D deficiency on post transplant outcomes : A Randomised, double blind placebo-controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077828
Enrollment
140
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Vitamin D Supplementation: Vitamin D3 60,000 IU given once weekly Pre Liver Transplant atleast for 6 weeks Control Intervention1: Placebo: Placebo capsules once weekly for atleast 6 wee

Sponsors

ILBS, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients with Cirrhosis of Liver and Vitamin D deficiency ( defined as levels less than 30 ng per ml) undergoing Liver Transplant

Exclusion criteria

Exclusion criteria: Negative consent Pediatric patients ALF DDLT Retransplant Patients already receiving Vitamin D supplements. K/C/O Hypo/ Hyperparathyroidism H/o other Solid Organ Transplantation Patients needing urgent Liver transplant before 6 weeks of Vitamin D Supplementation. Patients with Vitamin D levels less than 10 ng per ml Patients with Osteoporosis ( DEXA BMD T Score less than -2.5)

Design outcomes

Primary

MeasureTime frame
To compare the Post Liver Transplant bacterial infection rates in the first 3 months between the two arms.Timepoint: 3 months post liver transplant—

Secondary

MeasureTime frame
To compare the Acute Graft Rejection rates between the two arms within 3 months post liver transplant.Timepoint: 3 months post liver transplant;To compare the Sepsis (Bacterial and Fungal) and septic shock rate between the two arms within 3 months post liver transplantTimepoint: 3 months post liver transplant;To compare the Serum Vitamin D3 levels and Bone mineral Density (T score) between the two arms at 3 months post liver transplant.Timepoint: 3 months post liver transplant;To compare the Bone formation marker : osteocalcin (OC) and bone resorption marker : carboxyl-terminal telopeptide of type 1 collagen (CTX-1) between the two arms 3 months post liver transplant.Timepoint: 3 months post liver transplant;To compare the Overall Survival between the two arms 3 months post liver transplant.Timepoint: 3 months post liver transplant—

Countries

India

Contacts

Public ContactNihar Mohapatra

Institute of Liver and Biliary Sciences

nihar0310@gmail.com9910479799

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026