Pilot study: Leucocyte actIvation and endothelial function after oral fat loading combined with VITamin D - LIVIT-D

• Conditions: Endothelial functionLeukocyte activationTriglyceride metabolismSkin autofluorescence; MedDRA version: 12.1Level: LLTClassification code 10003601Term: Atherosclerosis; MedDRA version: 12.1Level: LLTClassification code 10020870Term: Hypertriglyceridemia; MedDRA version: 12.1Level: LLTClassification code 10050713Term: Vitamin D

• Registration Number: EUCTR2010-024182-44-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>Pulse wave augmentation (%)<br>Skin autofluorescence (a.u.)<br>CD11b (a.u.)<br>CD66b (a.u.)<br>CD35 (a.u.)<br>CD36 (a.u.)