only healthy volunteers are involved
Conditions
Interventions
Trade Name: Ocuvite PreserVision®
Product Name: Ocuvite PreserVision®
Pharmaceutical Form: Tablet
INN or Proposed INN: vitamin A
Concentration unit: IU international unit(s)
Concentration type: equal
Sponsors
Medical University of Vienna; Clinical Pharmacology
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. -To investigate the effect of oral vitamins and minerals supplementation on impaired endothelial function caused by E coli endotoxin. -To investigate the effect of oral vitamins and minerals supplementation on cytokine plasma levels in LPS model. ;Primary end point(s): -Retinal blood flow | — |
Countries
Austria
Outcome results
None listed