healthy volunteers. The intended indication for the investigated product is prevention and treatment of immunological (e.g. type 1 diabetes), endocrine (e.g. endocrine hypertension), metabolic (e.g. dyslipidemia) and cardiovascular diseases.
Conditions
Interventions
Trade Name: Oleovit D3 Topfen
Product Name: Oleovit D3 Tropfen
Product Code: 10.989
Pharmaceutical Form: Oral drops*
Pharmaceutical form of the placebo: Oral drops*
Route of administration of the plac
Sponsors
Medizinische Universiätsklinik Graz, Abteilung für Endokrinologie und Nuklearmedizin
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 (>2,65mmol/L) Pregnancy Nursing women Any disease that requires continuous treatment with medications Intake of medication as part of another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate whether vitamin D supplementation significantly alters the insulin secretin (assessed by mixed meal tolerance test), renin, aldosterone, osteoprotegerin, high-density lipoprotein cholesterol and asymmetric dimethylarginine (ADMA) concentrations and the effect on different cytokine levels (IL1-beta, IL2, IL4, IL6, IL10, MCP1, TNF-alpha, Adiponectin, Leptin, Resistin, TGF-beta).;Main Objective: To evaluate whether vitamin D supplementation significantly alters the proportion of regulatory T-cells of all circulating CD4 positive T-cells.;Primary end point(s): Changes in the proportion of regulartory T-cells of all circulating CD4 positive T-cells | — |
Countries
Austria
Outcome results
None listed