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 | 17.0 |
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 administration of vitamin D3 (D-CURE®) with food will improve the absorption and increase serum levels of 25-hydroxyvitamin D3. |
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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 |
1)Male and female aged from 18 to 55 years inclusive
2)Caucasian
3)Having a 25-(OH) vitamin 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), 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 |
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)Abnormal thyroid function confirmed by an abnormal TSH;
5)Subjects who have a serum creatinine > 150 µmol/L (corresponding to 17 mg/L) at screening;
6)Subjects who have an albumin corrected serum calcium > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening;
7)Subject known to have, or at risk of contracting, Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or subjects with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab).
8)Use of any vitamin D supplement alone or in association within 2 months before the screening visit and during the study;
9)UV light solarium use 2 months before the screening visit and during the study;
10)Travelling to regions with high UVB incidence in the last 2 months and during the study;
11)History of drug and/or alcohol abuse;
12)Use of any prohibited medication as detailed in the concomitant medication section;
13)Participation in any other clinical trial within 1 month of the screening visit;
14)Hypersensitivity to the active ingredient and/or excipients of D-CURE®;
15)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) |
The change in 25-OH vitamin D serum level from baseline (before D-CURE administration) to the Day 14 measurement. |
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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 vitamin D serum level at each time point
-changes from baseline of 25-OH vitamin D serum level at each time point
- the area under the curve of 25-OH vitamin D serum level against time (60 days) after a single intake of D-CURE. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1, 3 ,5 ,7, 14 ±1, 30±2 and 60±3 of each period. |
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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 | No |
E.8.1.6 | Cross over | Yes |
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 |
same treatment but once taken with food, once taken without food |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | |