EUCTR2012-004917-14-BE进行中（未招募）1 期
A phase IV, randomised, double-blinded, parallel study to estimate the dose-response of vitamin D (D-CURE®) supplementation on the 25-hydroxyvitamin D serum concentration in patients with vitamin D deficiency.
ABORATOIRES SMB S.A0 个研究点开始时间: 2012年11月12日最近更新:
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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
- •Patients must satisfy the following criteria before entering the study:
- •1)Male and female over 18 years old (18 years inclusive);
- •2)Having a 25 OH-vitamin D =5 ng/ml and =20 ng/ml at the screening visit.
- •3)Presenting a Body mass Index between 18 and 30 kg/m² inclusive;
- •4)Normal function of thyroid confirmed by normal TSH with or without treatment
- •5)Caucasian;
- •6)Able to comply with all study procedures;
- •7)Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form;
- •8)If the patient 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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients 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 history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
- •3)Patients who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
- •4)Patients who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
- •5)Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab).
- •6)Use of any vitamin D supplementation alone or in association within 4 weeks before the screening visit;
- •7)Use of any of the prohibited medication as detailed in the concomitant medication section;
- •8)UV light solarium use 2 weeks before the screening visit and during the study;
- •9)Travelling outside European countries during the study participation;
- •10)History of drug and/or alcohol abuse;
- •11)Patients with any sensitivity or allergy to any of the products used within this clinical trial;
- •12)Participation in any other clinical trial within 1 month of the screening visit;
- •13)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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