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The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels (IRI in MRI)

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ClinicalTrials.gov Identifier: NCT00534924
Recruitment Status : Unknown
Verified September 2007 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Information provided by:
Medical University of Vienna

Brief Summary:

Ischemic injury to muscular tissue is common in cardiovascular medicine. The most effective treatment to avoid ischemic damage is the rapid re-establishment of reperfusion. However, reperfusion itself can result in additional damage to ischemic tissue. This phenomenon is called ischemia - reperfusion (IR) injury and is caused by different pathologic mechanisms.

Therapies are required which can be administered after the onset of an ischemic event to protect the tissue against IR injury. Therefore, a promising strategy to reduce IR injury is post-conditioning.

Likewise, pharmacological therapies administered after the onset of reperfusion might prevent tissue injury. We have recently shown that high concentrations of exogenous vitamin C abrogate experimental IR injury of the forearm vasculature in patients with peripheral artery disease and in healthy subjects.

Study hypothesis

We hypothesize that the administration of mechanical post-conditioning or of high-dose vitamin C may protect skeletal muscle against IR injury. This shall be studied employing MR spectroscopy of the leg, which is an established model to assess muscle aerobic energy metabolism.


Three periods, three way cross over study in 10 volunteers. One screening visit, three one-day study days with two washout periods of >3 days in between are scheduled for each participant. The order of experimental days will be randomized. After the last treatment a final follow-up examination will be performed within one week.

Condition or disease Intervention/treatment
Ischemia Reperfusion Injury Drug: Vit C Procedure: Postconditioning Other: no intervention

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Placebo Comparator: 1
No intervention after IR injury
Other: no intervention
Experimental: 2
Procedure: Postconditioning
Experimental: 3
Vit. C
Drug: Vit C

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men aged between 18 and 45 years
  • Nonsmoker for more than 3 months
  • Body mass index between 18 and 25 kg/m2
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

Any of the following will exclude a subject from the study:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
  • Treatment in the previous 3 weeks with any drug including over-the-counter drugs.
  • Symptoms of a clinically relevant illness in the 2 weeks before the first study day
  • History or presence of gastrointestinal, liver of kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
  • Blood donation during the previous 3 weeks
  • History of hypersensitivity to parenteral vitamin C.
  • Glucose-6-phosphate dehydrogenase deficiency
  • Thalassemia, haemochromatosis
  • History of urolithiasis
  • Any metallic or paramagnetic device not removable
  • Claustrophobia
  • Regular use of supplementary oral Vitamin C or Vitamin C containing substances

Information from the National Library of Medicine

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): NCT00534924

Contact: Martin Andreas, MD 0043404002983 martin.andreas@meduniwien.ac.at

Medical University of Vienna Recruiting
Vienna, Austria
Contact: Martin Andreas, MD    0043404002983    martin.andreas@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Michael Wolzt, MD, Prof. Head of research group

ClinicalTrials.gov Identifier: NCT00534924     History of Changes
Other Study ID Numbers: EudraCT: 2007-002520-16
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007

Keywords provided by Medical University of Vienna:
IR injury
Vitamin C

Additional relevant MeSH terms:
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents