Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans
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ClinicalTrials.gov Identifier: NCT00914576 |
Recruitment Status :
Completed
First Posted : June 5, 2009
Last Update Posted : July 24, 2013
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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: Placebo Drug: 100% Oxygen Drug: Escherichia coli Endotoxin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2011 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

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 Name: 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 Name: 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 Name: LPS (US Standard) |
- Retinal blood flow [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914576
Austria | |
Department of Clinical Pharmacology, Medical University of Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Gerhard Garhofer, MD | Department of Clinical Pharmacology, Medical University of Vienna |
Responsible Party: | Gerhard Garhofer, Prof. Dr., Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00914576 |
Other Study ID Numbers: |
OPHT-101108 |
First Posted: | June 5, 2009 Key Record Dates |
Last Update Posted: | July 24, 2013 |
Last Verified: | July 2013 |
Endotoxin, Escherichia Coli Retina Regional Blood Flow |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |