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
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