Healthy volunteers. The intended indication for the product under development is prevention and treatment of immunological (e.g. type 1 diabetes), endocrine (e.g. endocrine hypertension) metabolic (e.g. dyslipidemia), malignant and cardiovascular diseases.
Conditions
Interventions
Trade Name: OLEOVIT D3-Tropfen
Product Name: OLEOVIT D3-Tropfen
Pharmaceutical Form: Oral drops*
INN or Proposed INN: colecalciferol
Current Sponsor code: 10.989
Concentration unit: IU international u
Sponsors
Medical University of Graz, Department of Internal Medicine, Div. Endocrinology and Nuclear Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent Healthy volunteers, Age of at least 18 years. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hypercalcemia (>2,65 mmol/L) Pregnancy Nursing women Any disease that requires continuous treatment with medications Intake of medications as part of another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether vitamin D supplementation significantly alters the proportion of regulatory T-cells of all circulating CD4 positive T-cells.;Secondary Objective: To evaluate whether vitamin D supplementation significantly alters the HOMA (homeostasis model assessment) Index, renin, aldosterone, osteoprotegerin, high-density lipoprotein cholsterol and asymmetric dimethylarginine (ADMA) concentrations.;Primary end point(s): Changes in the proportion of regulatory T-cells of all circulating CD4 positive T-cells. | — |
Countries
Austria
Outcome results
None listed