Vitamin D deficiency (10-20 ng/ml) MedDRA version: 17.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: D-CURE
Pharmaceutical Form: Oral solution
INN or Proposed INN: CHOLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: D-CURE-IV-14-1
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Sponsors
LABORATOIRES SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 88 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether administration of vitamin D3 (D-CURE®) with food will improve the absorption and increase serum levels of 25-hydroxyvitamin D3.;Secondary Objective: Not applicable;Primary end point(s): The change in 25-OH vitamin D serum level from baseline (before D-CURE administration) to the Day 14 measurement.;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Day 1, 3 ,5 ,7, 14 ±1, 30±2 and 60±3 of each period. | — |
Countries
Belgium
Contacts
Public ContactCLINICAL DEPARTMENT
LABORATOIRES SMB S.A
Outcome results
None listed