NCT00397475已完成不适用
Evaluation of Colecalciferol Substitution in Dialysis Patients
University Hospital, Saarland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CD14/CD16-Monocyte-Subsets (Frequency)
研究概览
简要总结
The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system
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
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
- •Serum 25-OH-Vit.D-levels < 60 ng/ml
- •Age > 18 years
- •dialysis treatment > 3 Months
- •signed written informed consent
- •Serum-Calcium-levels < 2,6 mmol/l within the last 4 weeks
- •Serum-Phosphate-levels < 7,0 mg/dl within the last 4 weeks
- •Ca x P-Product < 75 mg2/dl2 within the last 4 weeks
排除标准
- •Serum 25-OH-Vit.-D-levels > 60 ng/ml
- •concommitant participation in another interventional trial
- •psychiatric disorders preventing from valid informed consent
- •Hyperphosphatemia (> 7,0 mg/dl) within the last 4 weeks
- •Hypercalcemia (> 2,6 mmol/l) within the last 4 weeks
- •Ca x P-Product > 75 mg2/dl2 within the last 4 weeks
- •pregnancy or lactation
- •known malignancy
- •liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
- •PTH levels < 50 pg/ml
- •current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
- •Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
- •Immunosuppressant Medication
- •known hematologic disorders, other than renal anemia
- •age below 18 years
- •known anaphylactic reaction against the study medication or other ingredients of the study drug preparation
- •renal calculus
- •Pseudohypoparathyroidism
- •Medication including cardiac glycosides
- •Sarkoidosis
结局指标
主要结局
CD14/CD16-Monocyte-Subsets (Frequency)
次要结局
- Production of Cytokines: IFN-γ, TNF-α
- Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase
- Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency
研究者
研究点 (1)
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