A phase IV, randomised, double-blinded, placebo-controlled, parallel study to estimate the influence of vitamin D (D-CURE®) supplementation on the 25-hydroxyvitamin D serum concentration in patients aged over 50 years.
- Conditions
- Patients are over 50 years old and do not present any significant medical conditions.MedDRA version: 12.1Level: LLTClassification code 10047626Term: Vitamin D deficiency
- Registration Number
- EUCTR2010-023510-32-BE
- Lead Sponsor
- aboratoires SMB S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method