Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- efficacy and safety of cholecalciferol therapy in dialysed patients
研究概览
简要总结
The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).
The main question it aims to answer is:
How does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?
Participants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.
详细描述
The analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care.
Specifically, we will analyze the levels of:
- 25(OH)D,
- 1,25(OH)2D
- Calcium
- Phosphates
- PTH
- FGF23
- GDF15 to assess the efficacy and safety of cholecalciferol in dialysis patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D < 30 ng/mL)
排除标准
- •dialysis time of less than 3 months
- •inadequately controled secondary hyperparathyroidism (iPTH>800pg/mL)
- •treatment with calcimimetics
- •treatment with active forms of vitamin D3,
- •parathyroidectomy
- •bilateral nephrectomy
- •treatment with corticosteroids
- •lack of consent to take part in the study.
研究组 & 干预措施
25(OH)D < 30 ng/mL
Dialysed patients with vitamin D level (25(OH)D) < 30 ng/mL administered cholecalciferol
干预措施: Cholecalciferol (Drug)
25(OH)D 30 - 49.9 ng/mL
Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol
干预措施: Cholecalciferol (Drug)
25(OH)D 50-80 ng/mL
Dialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
efficacy and safety of cholecalciferol therapy in dialysed patients
时间窗: 2022-2026
analysis of - vitamin D levels - 25(OH)D, 1,25(OH)2D, calcium-phosphate metabolism parameters (serum calcium, phosphate, PTH levels),FGF23, GDF15 levels, in 3 groups of patients achieving different range of 25(OH)D levels
次要结局
未报告次要终点