Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
NCT ID: NCT00431691
Last Updated: 2008-07-04
Study Results
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Basic Information
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COMPLETED
PHASE4
22 participants
INTERVENTIONAL
2006-09-30
2007-12-31
Brief Summary
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Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
vitamin and mineral supplement
dose: 4 tablets daily for two weeks
vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg
Escherichia coli Endotoxin (LPS)
dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days
100% O2
breathing for 30 minutes, 2 breathing periods on both study days
nitroglycerin
dose: 0,8 mg sublingual, applied during FMD measurements on both study days
2
Escherichia coli Endotoxin (LPS)
dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days
100% O2
breathing for 30 minutes, 2 breathing periods on both study days
nitroglycerin
dose: 0,8 mg sublingual, applied during FMD measurements on both study days
Interventions
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vitamin and mineral supplement
dose: 4 tablets daily for two weeks
vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg
Escherichia coli Endotoxin (LPS)
dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days
100% O2
breathing for 30 minutes, 2 breathing periods on both study days
nitroglycerin
dose: 0,8 mg sublingual, applied during FMD measurements on both study days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index between 15th and 85th percentile
* 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, ametropia \< 3 Dpt
Exclusion Criteria
* 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
18 Years
35 Years
MALE
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Department of Clinical Pharmacology, Medical University of Vienna
Principal Investigators
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Michael Wolzt, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology, Medical University of Vienna
Locations
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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, , Austria
Countries
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References
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Pemp B, Polska E, Karl K, Lasta M, Minichmayr A, Garhofer G, Wolzt M, Schmetterer L. Effects of antioxidants (AREDS medication) on ocular blood flow and endothelial function in an endotoxin-induced model of oxidative stress in humans. Invest Ophthalmol Vis Sci. 2010 Jan;51(1):2-6. doi: 10.1167/iovs.09-3888. Epub 2009 Aug 13.
Other Identifiers
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OPHT-110106
Identifier Type: -
Identifier Source: org_study_id