A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- proportion of patients with vitamin D adequacy
研究概览
简要总结
Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.
详细描述
The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months
- •25(OH)D < 30 ng/ml
- •able to provide inform consent form
排除标准
- •current ergocalciferol or cholecalciferol treatment
- •known allergy to ergocalciferol
- •active inflammation or infection
- •advanced stage of cancer
- •pregnancy
- •lactation
- •on immunosuppressive drugs or corticosteroids
结局指标
主要结局
proportion of patients with vitamin D adequacy
时间窗: 6 months
serum 25(OH)D more than 30 ng/ml
次要结局
- serum intact parathyroid hormone(6 months)
- serum calcium(6 months)
- muscle mass(6 months)
- serum phosphorus(6 months)
- muscle strength(6 months)
研究者
Piyawan Kittiskulnam
Associate Professor of Medicine
Chulalongkorn University