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 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.

Registration Number: EUCTR2008-007792-24-AT

Lead Sponsor: Medical University of Graz, Department of Internal Medicine, Div. Endocrinology and Nuclear Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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 (>2,65 mmol/L)
Pregnancy
Nursing women
Any disease that requires continuous treatment with medications
Intake of medications 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
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.

Secondary Outcome Measures