Patients of 18 years of age or more with vitamin D deficiency MedDRA version: 14.1 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: D-CURE
Pharmaceutical Form: Oral solution
INN or Proposed INN: CHOLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: D-CURE-IV-12-2
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Sponsors
LABORATOIRES SMB S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the dose-response effect and determine an adapted supplementation of vitamin D (D-CURE®) in patients with deficiency in vitamin D concentration.;Secondary Objective: Not applicable;Primary end point(s): Mean change from baseline to week 12 in the 25-hydroxyvitamin D serum concentration. ;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Percentage of patients reaching 25-hydroxyvitamin D serum concentrations superior to 20 ng/ml at the end of the study •Percentage of patients reaching 25-hydroxyvitamin D serum concentrations superior to 30 ng/ml at the end of the study •Time to raise the 25- hydroxyvitamin D serum concentration up to 20 ng/ml •Time to raise the 25- hydroxyvitamin D serum concentration up to 30 ng/ml ;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Belgium
Contacts
Public ContactCLINICAL DEPARTMENT
LABORATOIRES SMB S.A
Outcome results
None listed