跳至主要内容
临床试验/EUCTR2011-006163-22-ES
EUCTR2011-006163-22-ES进行中(未招募)不适用

Study to evaluate the pharmacokinetic of vitamin D (cholecalciferol) in patients with obesity after bariatric surgery in vitamin D deficiency and after normalization

Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2012年3月6日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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
Male

入选标准

  • - 18 or more years old
  • - with bariatric surgery in the last 18 months (+/- 6 months)
  • - BMI: 25-33 kg/m2
  • - vitamina D3 (OK)<20ng/mL.
  • - Clinically stable, in the opinion of the investigator, at the time of inclusion
  • - Signed consent form
  • 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 44
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 44

排除标准

  • - pregnancy, lactation or intention during the study period.
  • - menopause
  • - GOP, GPT>2 UNL
  • - glomerular filtration rate <60ml/min
  • - previous renal lithiasis
  • - any digestive disease to suggest malabsorption, granulomatous diseases, diabetic gastroenteropathy and taking medication likely to interfere with the absorption of vitamin D and bone metabolism such as corticosteroids and anticonvulsants
  • - taking medication that interferes with calcium meabolism.
  • - cholecalciferol hypersensitivity.
  • - other bariatric surgery (different of by-pass or tubular gastrectomy)

研究者

发起方
Fundació Clínic per a la Recerca Biomèdica

相似试验