Preoperative vitamin D supplementation for adults with cirrhosis and low vitamin D before liver transplant
Effect of Preoperative Vitamin D Supplementation in Liver Transplant Recipients With Vitamin D Deficiency on Post Transplant Outcomes
This trial will see if giving vitamin D before surgery helps adults with cirrhosis and vitamin D deficiency have fewer infections and better outcomes after liver transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06736093 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial gives preoperative vitamin D3 or placebo to adults with chronic liver disease who have vitamin D deficiency (<30 ng/ml) and are awaiting liver transplant. Patients are randomized before transplant and followed for post-transplant outcomes including infections and other complications. Key exclusions include pediatric patients, acute liver failure, deceased-donor or re-transplant cases, current vitamin D supplementation, very low vitamin D (<10 ng/ml), osteoporosis, and parathyroid disorders. The single-center trial is conducted at the Institute of Liver and Biliary Sciences in New Delhi.
Who should consider this trial
Good fit: Adults (>18 years) with cirrhosis listed for liver transplant who have vitamin D levels under 30 ng/ml (but not <10 ng/ml), are not already taking vitamin D, and can wait the preoperative supplementation period.
Not a fit: Patients with very severe deficiency (<10 ng/ml), osteoporosis (DEXA T-score ≤ -2.5), urgent or acute transplant needs, deceased-donor or re-transplant candidates, pediatric patients, or those already on vitamin D supplements are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce post-transplant infections and improve recovery and longer-term outcomes for vitamin D–deficient transplant recipients.
How similar studies have performed: Observational studies link low vitamin D to higher infection risk and worse outcomes, but randomized preoperative vitamin D supplementation in liver transplant recipients has not been reported.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Institute of Liver and Biliary Sciences — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Principal investigator: Sridhar L, MS — Institute of Liver and Biliary Sciences, New Delhi, India
- Study coordinator: Sridhar L, MS
- Email: sridharlrao1993@gmail.com
- Phone: +91-9738387083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.