EUCTR2008-002387-33-BE进行中（未招募）不适用
Impact of 25-hydroxy vitamin D deficiency and its correction on mineral and bone disorde among hemodialysis patients - VitaDial
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent
- •Age 18 years or older
- •End-stage renal disease on hemodialysis for at least 3 months (3 dialysis sessions or more per week)
- •Serum 25-OH vitamin D levels < 30 ng/mL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known hypersensibility to cholecalciferol or to any constituent of the study medication (D-cure ®)
- •Pregnancy or lactation period
- •Woman of childbearing potential without effective contraception
- •Cholecalciferol, calcitriol, paricalcitol or alfacalcidol dosage adjustment 1 month prior to enrolment
- •Serum corrected calcium level > 10.2 mg/dL
- •Participation in a clinical trial or receipt of investigational compound or treatment 3 months prior the enrolment
- •Parathyroidectomy
- •History of granulomatous disorder (sarcoidosis, tuberculosis)
- •History of malignancy with a life expectancy < 12 months
研究者
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