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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To compare the Post Liver Transplant bacterial infection rates in the first 3 months between the two arms.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients with Cirrhosis of Liver and Vitamin D deficiency ( defined as levels less than 30 ng per ml) undergoing Liver Transplant.
排除标准
- •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).
结局指标
主要结局
To compare the Post Liver Transplant bacterial infection rates in the first 3 months between the two arms.
时间窗: 3 months post liver transplant
次要结局
- To compare the Acute Graft Rejection rates between the two arms within 3 months post liver transplant.(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 transplant(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.(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.(3 months post liver transplant)
- To compare the Overall Survival between the two arms 3 months post liver transplant.(3 months post liver transplant)
研究者
Sridhar L
Institute of Liver and Biliary Sciences