The Effect of Normalizing Vitamin D Concentrations on Everlomius Trough Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Oral daily everolimus dose change
研究概览
简要总结
Vitamin D is part of the regular treatment regimen among patients after heart transplantation. Due to potential drug-drug interaction between vitamin D and everolmus, these patients are in increased risk for increased everolimus metabolism, potentially leading to under- immunosupression.
详细描述
post heart transplantation patients treated with everolimus will be screened for vitamin D levels. Patients defined as deficient will be treated with vitamin D with close and intensive monitoring everolimus levels, adjusting oral daily dose to maintain therapeutic levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplanted patients treated with everolimus
排除标准
- 未提供
研究组 & 干预措施
No vitamin D deficiency
Regular and routine monitoring
Vitamin D deficient
Vitamin D supplementation and close everolimus trough levels monitoring with oral dose adjustments
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Oral daily everolimus dose change
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Dr.Itai Gueta
Physician in the institute for clinical pharmacology
Sheba Medical Center