EUCTR2008-002807-21-AT进行中(未招募)1 期
VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the posttransplant outcome - VITA-D
MUW, Universitätsklinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse0 个研究点目标入组 200 人开始时间: 2008年9月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 200
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
- •Deceased donor kidney transplant recipients
- •Only kidney transplant recipients
- •Vitamin D deficiency defined as 25OHD <50nmol/l
- •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
- •Re-transplantation for the second time if the patient is highly immunized and therefore included in the apheresis program
- •Re-transplantation for the third time or more often
- •Significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mukoviscidosis, Zollinger-Ellison-syndrom
- •History of inflammatory bowel disease: Crohn’s disease, Ulcerative Colitis
- •Previouse gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
- •Severe liver disease: cirrhosis
- •HIV positive (HAART enhances Vitamin D catabolism)
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