Effect of antioxidants on ocular blood flow, endothelial function, and cytokine levels in LPS induced inflammatory model in humans. - LPS/AREDS

• Conditions: only healthy volunteers are involved

• Registration Number: EUCTR2006-002273-41-AT
• Lead Sponsor: Medical University of Vienna; Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-08
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

-Men aged between 18 and 35 years, nonsmokers
-Body mass index between 15th and 85th percentile (Must et al. 1991)
-Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
-Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
-Normal ophthalmic findings, ametropy < 3 Dpt.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
-Treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as well
-Symptoms of a clinically relevant illness in the 3 weeks before the first study day
-History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
-History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
-Blood donation during the previous 3 weeks

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.;Secondary Objective: -To investigate the effect of oral vitamins and minerals supplementation on ocular blood flow during inflammation.<br>-To investigate the effect of oral vitamins and minerals supplementation on impaired endothelial function caused by E coli endotoxin.<br>-To investigate the effect of oral vitamins and minerals supplementation on cytokine plasma levels in LPS model.<br>;Primary end point(s): -Retinal blood flow