EUCTR2016-003755-29-BE进行中（未招募）1 期
A phase IV, randomised, parallel study to compare a monthly administration of vitamin D3 (D-CURE®) to a daily administration of vitamin D3 (VISTA-D3®).
ABORATOIRES SMB S.A0 个研究点开始时间: 2016年10月28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
- •Subjects must satisfy the following criteria before entering the study:
- •1)Male and female aged from 18 to 55 years inclusive;
- •2)Caucasian
- •3)Having a 25(OH)D3 =10 ng/ml and = 20 ng/ml at the screening visit.
- •4)Presenting a body mass index (BMI) between 18 and 25 kg/m² inclusive;
- •5)Able to comply with all study procedures;
- •6)Provide written informed consent to participate in the study, indicated by a personal signature and date on the subject consent form;
- •7)If the volunteer is female and of childbearing potential, she must be using an efficient means of birth control (IUD, OCS, spermicide + condom, vaginal ring, hormonal patch, implant), as determined by the investigator and provide a negative blood pregnancy test at the screening visit.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Subjects who meet any of the following criteria will be excluded from participating in the study:
- •1)Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease;
- •2)Past or current granulomatosis (Besnier-Boek-Schaumann disease), sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
- •3)Abnormal digestive functions (obstructive jaundice, pancreatic insufficiency, cystic fibrosis, celiac disease, etc);
- •4)Subjects who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
- •5)Subjects who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
- •6)Subjects known to have, or at risk of contracting, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •7)Use of any vitamin D supplement alone or in association within 2 months before the screening visit and during the study;
- •8)UV light solarium use 2 months before the screening visit and during the study;
- •9)Travelling to regions with high UVB incidence in the last 2 months and during the study;
- •10)History of drug and/or alcohol abuse;
- •11)Use of any prohibited medication as detailed in the concomitant medication section;
- •12)Participation in any other clinical trial within 1 month of the screening visit;
- •13)Hypersensitivity to the active ingredient and/or excipients of D-CURE® or VISTA-D3®;
- •14)Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
研究者
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