Vitamin D deficiency (10-20 ng/ml) MedDRA version: 19.0 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-16-1
Other descriptive name: CHOLECALCIFEROL CONCENTRATE
Sponsors
LABORATOIRES SMB S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 25(OH)D3 serum concentrations at day 75;Timepoint(s) of evaluation of this end point: Day 75 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: day 2, 4, 7, 14, 25, 50, 75 and 105 | — |
Countries
Belgium
Contacts
Public ContactDEPARTEMENT CLINIQUE
LABORATOIRES SMB S.A
Outcome results
None listed