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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00914576
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 5, 2009
Last Update Posted Date July 24, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Retinal blood flow [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans
Official Title  ICMJE Effect of Antioxidants on Oxygen Induced Vasoconstriction in LPS Induced Inflammatory Model in Humans
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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: 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)
Study Arms  ICMJE
  • Active Comparator: 1
    Interventions:
    • Drug: Vitamin and mineral supplement
    • Drug: Vitamin and mineral supplement
    • Drug: 100% Oxygen
    • Drug: Escherichia coli Endotoxin
  • Placebo Comparator: 2
    Interventions:
    • Drug: Placebo
    • Drug: 100% Oxygen
    • Drug: Escherichia coli Endotoxin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00914576
Other Study ID Numbers  ICMJE OPHT-101108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerhard Garhofer, MD Department of Clinical Pharmacology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP