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临床试验/EUCTR2012-001449-42-AT
EUCTR2012-001449-42-AT进行中(未招募)1 期

A randomized, double-blind, placebo controlled trial to evaluate vitamin D supplementation on serum 25 hydroxy- vitamin D level in cirrhotic patients - VIT D Cirr

Medizinische Universität Graz, Kl. Abt. f. Endokrinoloie u. Stoffwechsel & Kl. Abt. f. Gastroenterologie u. Hepatologie0 个研究点目标入组 100 人开始时间: 2014年1月16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
100

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

  • 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
  • Compensated and decompensated cirrhosis diagnosed by the hepatologist for at last three months previous study baseline
  • Age of = 18 years
  • Written informed consent
  • 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 75
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • Hypercalcemia defined a serum calcium >2.65 mmol/L
  • Pregnancy or lactating women
  • Drug intake as part of another clinical study
  • Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
  • Any disease with an estimated life expectancy below 1 year
  • Any clinically significant acute disease requiring drug treatment
  • Chemotherapy or radiation therapy during the study
  • Regular intake of more than 880 International Units (IU) vitamin D in the last twelve weeks before study entry or during the study

研究者

发起方
Medizinische Universität Graz, Kl. Abt. f. Endokrinoloie u. Stoffwechsel & Kl. Abt. f. Gastroenterologie u. Hepatologie

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