To evaluate whether vitamin D supplementation in type 1 diabetic subjects significantly alters the proportion of regulatory T-cells of all circulating CD4 positive T-cells.
Conditions
Interventions
Trade Name: Oleovit D3 Tropfen
Product Name: Oleuvit D3 Tropfen
Product Code: 10.989
Pharmaceutical Form: Oral drops
Concentration unit: IU international unit(s)
Concentration type: equal
Pharmaceutic
Sponsors
Medical University Graz, Department of Internal Medicine, Div. Endocrinology and Metabolism
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent Healthy volunteers with type 1 diabetic Age of at least 6 years Are the trial subjects under 18? yes 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 |
|---|---|
| Main Objective: To evaluate whether vitamin D supplementation in type 1 diabetic subjects significantly alters the proportion of circulating CD4 positive T-cells. in type 1 diabetic subjects ;Secondary Objective: To evaluate whether vitamin D supplementation significantly alters the insulin secretin (assessed by mixed meal tolerance test), renin, aldosterone, osteoprotegerin, and asymmetric dimethylarginine (ADMA) concentrations and the effect on different cytokine levels (IL1-beta, IL2, IL4, IL6, IL10, MCP1, TNF-alpha, TGF-beta).;Primary end point(s): Changes in the proportion of regulartory T-cells of all circulating CD4 positive T-cells in type 1 diabetics | — |
Countries
Austria
Outcome results
None listed