A phase IV, randomised, cross-over study to estimate the influence of food on the 25-hydroxyvitamin D3 serum level after vitamin D3 (D-CURE®) supplementation.

ABORATOIRES SMB S.A.0 个研究点目标入组 88 人开始时间: 2014年9月16日最近更新: 2020年8月18日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 88

研究概览入排标准研究者记录与标识符相似试验

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

•1)Male and female aged from 18 to 55 years inclusive
•2)Caucasian
•3)Having a 25-(OH) vitamin 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), 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 88
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•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)Abnormal thyroid function confirmed by an abnormal TSH;
•5)Subjects who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
•6)Subjects who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
•7)Subject known to have, or at risk of contracting, Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or subjects with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab).
•8)Use of any vitamin D supplement alone or in association within 2 months before the screening visit and during the study;
•9)UV light solarium use 2 months before the screening visit and during the study;
•10)Travelling to regions with high UVB incidence in the last 2 months and during the study;
•11)History of drug and/or alcohol abuse;
•12)Use of any prohibited medication as detailed in the concomitant medication section;
•13)Participation in any other clinical trial within 1 month of the screening visit;
•14)Hypersensitivity to the active ingredient and/or excipients of D-CURE®;
•15)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

发起方

ABORATOIRES SMB S.A.

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