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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00914576
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Vitamin and mineral supplement; Drug: Vitamin and mineral supplement; Drug: Placebo; Drug: 100% Oxygen; Drug: Escherichia coli Endotoxin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Antioxidants on Oxygen Induced Vasoconstriction in LPS Induced Inflammatory Model in Humans
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Vitamin and mineral supplement; 1 capsule/day in the morning for 14 days, containing: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, Ginko Biloba 10mg, Flavonoids 25mg, Fish oil 300mg; Other Names: Vitamac Day ; Drug: Vitamin and mineral supplement; 1 capsule/day in the evening for 14 days, containing: Zeaxanthin 5mg, Vitamin E 60mg, Copper 1mg, Selene 20µg, Ginko Biloba 10mg, Flavonoids 25mg, Alpha Lipon acid: 150mg; Drug: 100% Oxygen; breathing of 100% O2 for 30 minutes on both study days; Drug: Escherichia coli Endotoxin; Escherichia coli Endotoxin (LPS, US Standard Reference Endotoxin, dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.; Other Names: LPS (US Standard)
Placebo Comparator: 2	Drug: Placebo; 2 capsules/day for 14 days; Drug: 100% Oxygen; breathing of 100% O2 for 30 minutes on both study days; Drug: Escherichia coli Endotoxin; Escherichia coli Endotoxin (LPS, US Standard Reference Endotoxin, dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.; Other Names: LPS (US Standard)

Outcome Measures

Primary Outcome Measures

1. Retinal blood flow [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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, ametropia < 3 Dpt

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Gerhard Garhofer, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Prof. Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00914576
• Other Study ID Numbers: OPHT-101108
• First Posted: Jun 5, 2009
• Last Update Posted: Jul 24, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Gerhard Garhofer, Prof. Dr., Medical University of Vienna: Endotoxin, Escherichia Coli; Retina; Regional Blood Flow
• Additional relevant MeSH terms: Vitamins

Study Results

No Results Posted as of Jul 24, 2013