drugset / Trial / NCT00914576

Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans

NCT00914576

Completed 40 enrolled Medical University of Vienna
RandomizedParallel-groupTriple-blindBasic science

Summary

Oxidative stress has been implicated in playing a pathogenic role in many disease processes, especially in age-related disorders. It has been hypothesized that antioxidative agents such as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for patients with age-related disorders. Based on this hypothesis, several different combinations of vitamins have been introduced, all targeting at reducing oxidative stress. However, the in-vivo determination of the antioxidative properties of a certain drug or vitamin combination are hard to determine. In the current study, the researchers propose to investigate the effect of VITAMAC®, a combination of vitamins and minerals, in a systemic in-vivo inflammation model. 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 inflammation in humans. Given that inflammation is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS model is well suitable for determination of the antioxidative effects of VITAMAC®. As a main outcome parameter, the vascular reactivity of retinal vessels to systemic hyperoxia (induced by breathing 100% oxygen) will be tested in presence or absence of the antioxidant combination.

Timeline

Start
2011-04
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alpha Lipon acid Unknown 150 mg
Comparator Copper Unknown 1 mg
Comparator Fish oil Other / unclassified 300 mg
Comparator Ginko Biloba Unknown 10 mg
Comparator Lutein Other / unclassified 12 mg
Comparator Resveratrol Small molecule 25 mg
Comparator Selene Unknown 20 ug
Comparator Vitamin C Other / unclassified 300 mg
Comparator Vitamin E Other / unclassified 60 mg
Comparator Zeaxanthin Small molecule 5 mg
Comparator Zinc Sulfate Unknown 10 mg

Indications

No indication recorded.