E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitamin D deficiency (10-20 ng/ml) |
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E.1.1.1 | Medical condition in easily understood language |
Vitamin D deficiency (10-20 ng/ml) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 whether a cumulative dose of vitamin D3 produces the same effects on the serum concentration of 25-hydroxyvitamin D if it is given daily or monthly. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must satisfy the following criteria before entering the study:
1)Male and female aged from 18 to 55 years inclusive;
2)Caucasian
3)Having a 25(OH)D3 ≥10 ng/ml and ≤ 20 ng/ml at the screening visit.
4)Presenting a body mass index (BMI) between 18 and 25 kg/m² inclusive;
5)Able to comply with all study procedures;
6)Provide written informed consent to participate in the study, indicated by a personal signature and date on the subject consent form;
7)If the volunteer is female and of childbearing potential, she must be using an efficient means of birth control (IUD, OCS, spermicide + condom, vaginal ring, hormonal patch, implant), 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 |
Exclusion criteria
Subjects 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 granulomatosis (Besnier-Boek-Schaumann disease), sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
3)Abnormal digestive functions (obstructive jaundice, pancreatic insufficiency, cystic fibrosis, celiac disease, etc);
4)Subjects who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
5)Subjects who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
6)Subjects known to have, or at risk of contracting, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
7)Use of any vitamin D supplement alone or in association within 2 months before the screening visit and during the study;
8)UV light solarium use 2 months before the screening visit and during the study;
9)Travelling to regions with high UVB incidence in the last 2 months and during the study;
10)History of drug and/or alcohol abuse;
11)Use of any prohibited medication as detailed in the concomitant medication section;
12)Participation in any other clinical trial within 1 month of the screening visit;
13)Hypersensitivity to the active ingredient and/or excipients of D-CURE® or VISTA-D3®;
14)Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
25(OH)D3 serum concentrations at day 75 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• 25(OH)D3 serum concentration at day 2, 4, 7, 14, 25, 50 and 105.
•Cholecalciferol serum concentration at day 2, 4, 7, 14, 25, 50, 75 and 105.
•1,25-(OH)2D3 serum concentration at day 2, 4, 7, 14, 25, 50, 75 and 105.
•FGF23 serum concentration at day 2, 4, 7, 14, 25, 50, 75 and 105.
•PTH serum concentration at day 2, 4, 7, 14, 25, 50, 75 and 105.
•Calcium corrected by albumin serum concentration day 2, 4, 7, 14, 25, 50, 75 and 105.
•Percentage of patients reaching 25(OH)D3 serum concentration superior to 20 and 30 ng/ml at the end of the study.
•Time to reach 25(OH)D3 serum concentration superior to 20 and 30 ng/ml. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
day 2, 4, 7, 14, 25, 50, 75 and 105 |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 15 |