EUCTR2010-022454-17-BE进行中（未招募）1 期
A double-blind, placebo controlled, randomized, comparative, mono-centre trial to assess the impact of a monthly administration of 50.000 IU of Vitamin D during 6 months on Vitamin D level in healthy young adult volunteers. - D-plus
niversity of Liège- Dpt de Médecine Générale0 个研究点开始时间: 2010年9月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- All
入选标准
- •-Healthy young adults, male or female
- •-18-30 years
- •-Willing to give informed consent in writing
- •-French speaking
- •-Mental and legal capacity to give his consent
- •-Body mass index between (=) 18 and (=) 30 kg/m2
- •-Availability to study visits
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject using any over-the-counter medicinal products, herbal supplements within the last 30 days containing vitamin D within the last 2 months;
- •2.UV light solarium use
- •3.Subject treated for epilepsy (phenytoïn, phenobarbital, carbamazepin)
- •4.Subject treated with glucocorticoïds;
- •5.Subjects treated with digitalin, Calcium, thiazidics,
- •6.Past or current history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer (of whatever origin), osteomalacia
- •7.Subject currently participating or within the last 3 months participated in another study of an Investigational Medicinal Product (IMP) that is a chemical entity or a medical device.
- •8.Subject with hypersensitivity or intolerance to any components of the IMP.
- •9.Subject has concurrent or past medical, surgical or psychiatric history that could, in the opinion of investigator, confound study interpretation or affect the subject’s ability to fully participate in the study.
- •10.Subject known to be positive for human immunodeficiency virus (HIV).
- •11.Known tuberculosis (TB) disease, high risk of acquiring TB infection
- •12.Subject known to have a history of acute chronic alcohol or drug abuse/dependence (including but not limited to cannabis) within the 6 months prior to Screening
- •13.Subject has a history of radiotherapy or chemotherapy
研究者
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