Vitamine D deficiency MedDRA version: 12.1 Level: LLT Classification code 10047626 Term: Vitamin D deficiency
Conditions
Interventions
Trade Name: D-cure®.
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: D-plus
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER
Sponsors
University of Liège- Dpt de Médecine Générale
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy young adults, male or female - 18-30 years - Willing to give informed consent in writing - French speaking - Mental and legal capacity to give his consent - Body mass index between (=) 18 and (=) 30 kg/m2 - Availability to study visits 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject using any over-the-counter medicinal products, herbal supplements within the last 30 days containing vitamin D within the last 2 months; 2. UV light solarium use 3. Subject treated for epilepsy (phenytoïn, phenobarbital, carbamazepin) 4. Subject treated with glucocorticoïds; 5. Subjects treated with digitalin, Calcium, thiazidics, 6. Past or current history of granulomatosis (Besnier-Boek-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer (of whatever origin), osteomalacia 7. Subject currently participating or within the last 3 months participated in another study of an Investigational Medicinal Product (IMP) that is a chemical entity or a medical device. 8. Subject with hypersensitivity or intolerance to any components of the IMP. 9. Subject has concurrent or past medical, surgical or psychiatric history that could, in the opinion of investigator, confound study interpretation or affect the subject’s ability to fully participate in the study. 10. Subject known to be positive for human immunodeficiency virus (HIV). 11. Known tuberculosis (TB) disease, high risk of acquiring TB infection 12. Subject known to have a history of acute chronic alcohol or drug abuse/dependence (including but not limited to cannabis) within the 6 months prior to Screening 13. Subject has a history of radiotherapy or chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to evaluate the mean change versus baseline of a monthly administration of 50.000 I.U. 25 hydroxy-Vitamin D, during six consecutive months on plasma levels of Vit D in young healthy volunteers.;Secondary Objective: Secondary objectives: to evaluate the influence of Vit D supplementation on muscle strength, fatigue and infectious episodes frequently encountered during winter (rhinitis, pharyngitis, otitis, Influenza, and G.I. tract infections).;Primary end point(s): The primary efficacy endpoint is the mean change in 25-hydroxy Vitamin D levels between the baseline (D1) and the treatment period (D3). The mean change will be calculated as the ratio R=D3/D1 or its logarithm log (R). The mean changes in 25-hydroxy Vitamin D levels (primary endpoint) in the two study groups (investigational and comparator) will be compared by a two-sided Student t-test at the 5% significance level, based on the ITT population. | — |
Countries
Belgium
Outcome results
None listed