Endothelial function Leukocyte activation Triglyceride metabolism Skin autofluorescence MedDRA version: 12.1 Level: LLT Classification code 10003601 Term: Atherosclerosis MedDRA version: 12.1 Level: LLT Classification code 10020870 Term: Hypertriglyceridemia MedDRA version: 12.1 Level: LLT Classification code 10050713 Term: Vitamin D
Conditions
Interventions
Product Name: Cholecalciferol
Product Code: Cholecalciferol
Pharmaceutical Form: Oral liquid
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: healthy volunteers aged 18 years or older. 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: The use of any kind of medication except oral contraceptives, medical history of vascular diseases or rhythm disorders, or participation in a clinical trial less than 6 months before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish a well founded power calculation for continuation of this pilot study on a larger scale. ;Secondary Objective: The relation of vitamin D with postprandial lipemia, postprandial leukocyte activation, skin autofluorescence and postprandial endothelial function will be explored in a pilot setting.;Primary end point(s): Pulse wave velocity (m/s) Pulse wave augmentation (%) Skin autofluorescence (a.u.) CD11b (a.u.) CD66b (a.u.) CD35 (a.u.) CD36 (a.u.) | — |
Countries
Netherlands
Outcome results
None listed