E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients are over 50 years old and do not present any significant medical conditions. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine an adapted supplementation of vitamin D (D-CURE®) in regard to the baseline vitamin D concentration of the patients |
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E.2.2 | Secondary objectives of the trial |
To assess and compare the safety of the test product versus placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change from baseline to week 12 in the 25-hydroxyvitamin D serum concentration. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |