Placebo controlled study on effects of vitamin D supplementation in healthy women and men on immunological, endocrine and metabolic parameters
Phase 1
- Conditions
- 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.
- Registration Number
- EUCTR2009-015523-91-AT
- Lead Sponsor
- Medizinische Universiätsklinik Graz, Abteilung für Endokrinologie und Nuklearmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Hypercalcemia (>2,65mmol/L)
Pregnancy
Nursing women
Any disease that requires continuous treatment with medications
Intake of medication as part of another clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method