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临床试验/EUCTR2008-002807-21-AT
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)

研究者

发起方
MUW, Universitätsklinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse

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