Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Healthy |
Drug: Vitamin and mineral supplement Drug: Placebo Drug: 100% Oxygen Drug: Escherichia coli Endotoxin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Antioxidants on Oxygen Induced Vasoconstriction in LPS Induced Inflammatory Model in Humans |
- Retinal blood flow [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders 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| Contact: Gerhard Garhofer, MD | 00431 40400 ext 2981 | gerhard.garhoefer@meduniwien.ac.at |
| Austria | |
| Department of Clinical Pharmacology, Medical University of Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Gerhard Garhofer, MD 00431 40400 ext 2981 gerhard.garhoefer@meduniwien.ac.at | |
| Principal Investigator: | Gerhard Garhofer, MD | Department of Clinical Pharmacology, Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Gerhard Garhofer, MD, Department of Clinical Pharmacology, Medical University of Vienna, Austria |
| ClinicalTrials.gov Identifier: | NCT00914576 History of Changes |
| Other Study ID Numbers: | OPHT-101108 |
| Study First Received: | June 3, 2009 |
| Last Updated: | June 15, 2011 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Medical University of Vienna:
|
Endotoxin, Escherichia Coli Retina Regional Blood Flow |
Additional relevant MeSH terms:
|
Antioxidants Vitamins Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013