RetinaPhase 4NCT00431691
Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
A Phase 4 study testing vitamin and mineral supplement, Escherichia coli Endotoxin (LPS) and 100% O2 in people with Retina and Regional Blood Flow, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Retina, Regional Blood Flow, Endotoxin, Escherichia Coli
- What is being tested?
- vitamin and mineral supplement, Escherichia coli Endotoxin (LPS) and 100% O2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2006to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged between 18 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous.
Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. 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 inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.
- Conditions
- Retina, Regional Blood Flow, Endotoxin, Escherichia Coli
- Being tested
- vitamin and mineral supplement, Escherichia coli Endotoxin (LPS), 100% O2, nitroglycerin
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin and mineral supplementDrug
Also called Ocuvite preservision
dose: 4 tablets daily for two weeks
vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg
Escherichia coli Endotoxin (LPS)Drug
Also called US Standard Endotoxin
dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days
100% O2Drug
breathing for 30 minutes, 2 breathing periods on both study days
nitroglycerinDrug
Also called Nitrolingual Pump Spray
dose: 0,8 mg sublingual, applied during FMD measurements on both study days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: vitamin and mineral supplement; Drug: Escherichia coli Endotoxin (LPS); Drug: 100% O2; Drug: nitroglycerin |
| 2 | Placebo comparator | Not described Receives: Drug: Escherichia coli Endotoxin (LPS); Drug: 100% O2; Drug: nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal blood flow
Measured: in total 8x on 2 study days
Secondary outcomes (5)
Choroidal blood flow
Measured: in total 4x on 2 study days
Flow mediated dilation (FMD) of brachial artery assessed with ultrasound
Measured: in total 4x on 2 study days
Blood pressure, heart rate
Measured: on 2 study days
Body temperature
Measured: on 2 study days
Concentration of cytokines in plasma
Measured: on 2 study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Michael Wolzt, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431691
- Sponsor's protocol ID
- OPHT-110106
- Status last verified
- Jul 2008
- First submitted
- 5 Feb 2007
- Last updated
- 4 Jul 2008
- Results posted
- No
Publications
Pemp B, Polska E, Karl K, Lasta M, Minichmayr A, Garhofer G, Wolzt M, Schmetterer L. Effects of antioxidants (AREDS medication) on ocular blood flow and endothelial function in an endotoxin-induced model of oxidative stress in humans. Invest Ophthalmol Vis Sci. 2010 Jan;51(1):2-6. doi: 10.1167/iovs.09-3888. Epub 2009 Aug 13.
PubMed 19684008
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
- ClinicalTrials.gov ID
- NCT00431691
- Acronym / sponsor ID
- OPHT-110106
- Conditions
- Retina, Regional Blood Flow, Endotoxin, Escherichia Coli
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates, has been implicated in many disease processes, especially age-related disorders. Many trials investigating use of antioxidants in protecting different tissues against oxidative stress have been conducted, but the results are ambiguous.
Inflammation is generally associated with enhanced oxidative stress and widespread endothelial dysfunction. 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 inflammatory response in humans. The assessment of outcome parameters will include measurements of ocular blood flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics provide an unique chance to investigate local blood flow in humans non-invasively. Moreover, the retina is especially susceptible to oxidative stress because of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light. Evidence from literature clearly supports a role for oxidative stress in pathophysiology of several ocular diseases including diabetic retinopathy and age-related macular degeneration. To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to assess endothelial function. The main study objective is to investigate the effect of oral vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: vitamin and mineral supplement, Drug: Escherichia coli Endotoxin (LPS), Drug: 100% O2, Drug: nitroglycerin |
| 2 | Placebo comparator | Drug: Escherichia coli Endotoxin (LPS), Drug: 100% O2, Drug: nitroglycerin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men aged between 18 and 35 years, nonsmokers
- Body mass index between 15th and 85th percentile
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin and mineral supplementAlso: Ocuvite preservisiondose: 4 tablets daily for two weeks vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg | Drug | 1 |
| Escherichia coli Endotoxin (LPS)Also: US Standard Endotoxindose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days | Drug | 1, 2 |
| 100% O2breathing for 30 minutes, 2 breathing periods on both study days | Drug | 1, 2 |
| nitroglycerinAlso: Nitrolingual Pump Spraydose: 0,8 mg sublingual, applied during FMD measurements on both study days | Drug | 1, 2 |
Primary outcome
Retinal blood flow
Time frame: in total 8x on 2 study days
5 secondary outcomes
Choroidal blood flow
Time frame: in total 4x on 2 study days
Flow mediated dilation (FMD) of brachial artery assessed with ultrasound
Time frame: in total 4x on 2 study days
Blood pressure, heart rate
Time frame: on 2 study days
Body temperature
Time frame: on 2 study days
Concentration of cytokines in plasma
Time frame: on 2 study days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
- Derived from this study: PubMed 19684008Pemp B, Polska E, Karl K, Lasta M, Minichmayr A, Garhofer G, Wolzt M, Schmetterer L. Effects of antioxidants (AREDS medication) on ocular blood flow and endothelial function in an endotoxin-induced model of oxidative stress in humans. Invest Ophthalmol Vis Sci. 2010 Jan;51(1):2-6. doi: 10.1167/iovs.09-3888. Epub 2009 Aug 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin and mineral supplement, Escherichia coli Endotoxin (LPS) and 100% O2 in people with Retina and Regional Blood Flow, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal blood flow (time frame: in total 8x on 2 study days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2008.