Patients are over 50 years old and do not present any significant medical conditions MedDRA version: 15.0 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: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: D-CURE-IV-12-1
Other descriptive name: COLECALCIFEROL CONCENTRATE (W
Sponsors
LABORATOIRES SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Volunteers must satisfy the following criteria before entering the study: 1)Male and female over 50 years old (50 years inclusive); 2)Presenting a Body Mass Index (BMI) between 18 and 35 kg/m² inclusive; 3)Able to comply with all study procedures; 4)Provide written, informed consent to participate in the study, indicated by a personal signature and date on the volunteer consent form; 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) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Volunteers who meet any of the following criteria will be excluded from participating in the study: 1)Volunteers with any sensitivity or allergy to any of the products used within this clinical trial; 2)Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease; 3)Use of drugs which may interfere with vitamin D metabolism e.g phenobarbital, phenytoin, oral and parenteral glucocorticoids; 4)Use of any vitamin D supplement alone or in association (multivitamin, vitamin D/calcium combination, vitamin D/biphosphonate combination) within 4 weeks before the screening visit. 5)UV light solarium used 2 weeks before the screening visit and during the study; 6)Participation in any other clinical trial with active substances within 2 months of the screening visit; 7)History of drug and/or alcohol abuse; 8)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: The aim of the present study is to assess the compliance of a once-a-month administration of vitamin D3 (D-CURE®) to a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®) during two periods of 6 months and to see their effect on the level of vitamin D. ;Secondary Objective: Not applicable;Primary end point(s): To compare the percentage of compliant volunteers between volunteers receiving the administration of a once-a-month administration of vitamin D3 (D-CURE®) and those receiving a daily administration of a fixed-dose combination of vitamin D3 and calcium (STEOVIT FORTE®).;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To compare the mean change from baseline (Month 0) in the 25-OH vitamin D serum concentration at the end of the first 6-month period (Month 6) •To compare the mean change from Month 6 in the 25-OH vitamin D serum concentration at the end of the second 6-month period (Month 12) •To assess treatment preference •To assess treatment persistence •To assess treatment acceptability ;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Belgium
Contacts
Public ContactCLINICAL DEPARTMENT
LABORATOIRES SMB S.A.
Outcome results
None listed