Patients are over 50 years old and do not present any significant medical conditions. MedDRA version: 12.1 Level: LLT Classification code 10047626 Term: Vitamin D deficiency
Conditions
Interventions
Trade Name: D-CURE®
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: D-CURE-IV-10-1
Other descriptive name: COLECALCIFEROL CONCENTRATE (
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female over 50 years old (50 years inclusive); Caucasian; Presenting a Body mass Index between 18 and 35 kg/m² inclusive; Able to comply with all study procedures; Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form; If the patient is female and of childbearing potential, she must be using an efficient means of birth control, 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease; Patients presenting a thyroid gland dysfunction; UV light solarium use 2 weeks before the screening visit; Use of drugs which may interfere with vitamin D metabolism e.g Phenobarbital, Phenytoin, glucocorticoids; Past or current history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia; Patients who present a vitamin D concentration > 60 ng/ml at screening; Patients who have a serum creatinine > 150 µmol/L at screening; Patients who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening; Use of any of the prohibited medication as detailed in the concomitant medication section; Participation in any other clinical trial within 2 months of the screening visit; Travelling outside European countries during the study participation; Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study; Patients with any sensitivity or allergy to any of the products used within this clinical trial; History of drug and/or alcohol abuse; 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine an adapted supplementation of vitamin D (D-CURE®) in regard to the baseline vitamin D concentration of the patients;Secondary Objective: To assess and compare the safety of the test product versus placebo.;Primary end point(s): Mean change from baseline to week 12 in the 25-hydroxyvitamin D serum concentration. | — |
Countries
Belgium
Outcome results
None listed