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Feasibility study to use new techniques/biomarkers to measure oxidative stress and the influence of vitamin E&C on these parameters in patienst suffering from intermittent claudication.


- candidate number1752
- NTR NumberNTR392
- ISRCTNISRCTN69086952
- Date ISRCTN created23-feb-2007
- date ISRCTN requested28-okt-2005
- Date Registered NTR10-okt-2005
- Secondary IDsMETC 0114 / 0112 X 
- Public TitleFeasibility study to use new techniques/biomarkers to measure oxidative stress and the influence of vitamin E&C on these parameters in patienst suffering from intermittent claudication.
- Scientific TitleFeasibility study to use new techniques/biomarkers to measure oxidative stress and the influence of vitamin E&C on these parameters in patienst suffering from intermittent claudication.
- ACRONYM0112 X
- hypothesisMultivariate Nuclear Magnetic Resonance (NMR) can be used to measure oxidative stress in patients suffering from intermittent claudication.
- Healt Condition(s) or Problem(s) studiedIntermittent claudication
- Inclusion criteriaStable (more than 6 months regarding subjective walking distance) patients with claudication intermittens.
- Exclusion criteriaPatients with pre-existing renal dysfunction and those not able to perform a standard walking test.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2002
- planned closingdate1-apr-2004
- Target number of participants13
- InterventionsPatients will receive antioxidant supplementation with high concentrations of vitamin E (200 mg/day) and vitamin C (1000 mg/day) during 4 weeks.
- Primary outcomeLevels of 'new' parameters of oxidative stress like isofuranes and halogenated phospholipids are determined. Also vascular parameters (fibrinogen, PAI-1 activity etc) and endothelial damage parameters (soluble thrombomodulin, von Willebrand factor etc) are determined. New techniques like multivariate NMR will be determined for their usefulness in the above mentioned type of studies.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. Ir. H.L. Vader
- CONTACT for SCIENTIFIC QUERIESDr. Ir. S.A.J. Coolen
- Sponsor/Initiator Unilever Research Vlaardingen, Unilever Health Institute , Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Máxima Medical Center, Unilever Research Vlaardingen, Unilever Health Institute
- PublicationsNMR Biomed. 2008 Feb 1. [Epub ahead of print]
- Brief summaryThe feasibility to use new techniques like multivariate NMR in studies on oxidative stress in vascular diseases is determined. Patients suffering from claudication intermittens are followed during exercise on a standard treadmill. Under these conditions the patients are exposed to an increased level of oxidative stress. Levels of 'new' biomarkers for oxidative stress are compared with levels of more traditional biomarkers for this condition. New techniques like multivariate NMR are examined for their usefulness in the above mentioned type of studies.
- Main changes (audit trail)
- RECORD10-okt-2005 - 12-jun-2008


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