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 sitesNovember 12, 2012

Overview

No summary available.

Registry

who.int

Start Date

November 12, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ABORATOIRES SMB S.A

•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

•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;