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Effects of Vitamin C on Hyperoxia-Induced Reduction of Retinal Blood Flow

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00712907
First received: July 8, 2008
Last updated: July 9, 2008
Last verified: July 2008
History of Changes
  Purpose

High arterial blood oxygen tension leads to vasoconstriction of retinal vessels, possibly related to an interaction between reactive oxygen species and endothelium-derived vasoactive factors. Vitamin C is a potent antioxidant capable of reversing endothelial dysfunction due to increased oxidant stress. Vitamin C appears to have vasodilatory properties, but the underlying mechanisms are not well understood.

In the present study we hypothesized that hyperoxic vasoconstriction of retinal vessels could be diminished by vitamin C.

Ocular blood flow will be determined by non-invasive methods, including laser Doppler velocimetry and the Zeiss retinal vessel analyser.


Condition Intervention
Ocular Physiology
Regional Blood Flow
 Dietary Supplement: vitamin C (Mayrhofer) 24mg/min i.v. for 64 min
Dietary Supplement: Placebo
Other: 100% O2 (AGA) two times for 12 min

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Effects of Vitamin C on Hyperoxia-Induced Reduction of Retinal Blood Flow

Resource links provided by NLM:

MedlinePlus related topics: Vitamin C
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Retinal arterial and venous diameter (Zeiss retinal vessel analyzer) [ Time Frame: in total 6 hours ] [ Designated as safety issue: No ]
  • Retinal blood flow velocity (laser Doppler velocimetry) [ Time Frame: in total 6 hours ] [ Designated as safety issue: No ]
  • Intraocular pressure (applanation tonometry) [ Time Frame: in total 10 minutes ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2003
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
vitamin C (Mayrhofer)
 Dietary Supplement: vitamin C (Mayrhofer) 24mg/min i.v. for 64 min
Substance: Ascorbic acid (Mayrhofer) Manufacturer: Mayrhofer, Linz, Austria Dosage form: i.v. Dosage: 24mg/min over 64 min Dosage reference: Ting HH 1996
Other: 100% O2 (AGA) two times for 12 min

Substance: 100% oxygen (AGA, Vienna, Austria, gases for human use) Manufacturer: AGA, Vienna, Austria, gases for human use Dosage form: Inhalation through an oxygenmask over a period of 12 minutes two times per study day.

Dosage reference: Strenn K 1997
Placebo Comparator: 2
Placebo
 Dietary Supplement: Placebo
Substance: Physiologic saline solution 0.9% (placebo) Dosage form: i.v. Dosage: 24ml/min over 64 min
Other: 100% O2 (AGA) two times for 12 min

Substance: 100% oxygen (AGA, Vienna, Austria, gases for human use) Manufacturer: AGA, Vienna, Austria, gases for human use Dosage form: Inhalation through an oxygenmask over a period of 12 minutes two times per study day.

Dosage reference: Strenn K 1997

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged between 19 and 35 years, nonsmokers
  • Body mass index between 15th and 85th percentile (Must A 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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712907

Locations
Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gabriele Fuchsjäger-Mayrl, MD, Department of Clinical Pharmacology
ClinicalTrials.gov Identifier: NCT00712907     History of Changes
Other Study ID Numbers: OPHT-161202
Study First Received: July 8, 2008
Last Updated: July 9, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
vitamin C
retinal blood flow
intraocular pressure
retinal vessel diameter

Additional relevant MeSH terms:
Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Ascorbic Acid
Vitamins
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013