EUCTR2012-003217-33-DE进行中（未招募）1 期
Immunological response of a single dose of 100,000 I.U. of cholecalciferol (vitamin D3)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •- written informed consent
- •- men and women aged between 18 - 60 years
- •- 25-hydroxyvitamin D3 serum concentration
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria
- •- 25-hydroxyvitamin D3 serum concentration >50 nmol/l
- •- BMI <18.5 or >30 kg/m²
- •- regular or planned UV exposure
- •- hypersensitivity against ingredients of the study drug
- •- anamnesis: any disease which is a contraindication for the IMP
- •- use of vitamin A or other vitamin D derivates
- •- treatment with any medication which might interfere with the study drug or is an contra indication
- •- pregnancy and lactation
研究者
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