Condition category
Circulatory System
Date applied
23/02/2007
Date assigned
23/02/2007
Last edited
26/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof H L Vader

ORCID ID

Contact details

P.O. Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 888 8900
h.vader@mmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

METC 0114/0112 X

Study information

Scientific title

Acronym

Study hypothesis

Multivariate Nuclear Magnetic Resonance (NMR) can be used to measure oxidative stress in patients suffering from intermittent claudication.

Ethics approval

Approval received by the Medical Ethical Review Board of Máxima Medical Centre in Eindhoven/Veldhoven on October 2, 2001 (ref: METC 0114).

Study design

Crossover feasability study

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Intermittent claudication

Intervention

Patients will receive antioxidant supplementation with high concentrations of vitamin E (200 mg/day) and vitamin C (1000 mg/day) during four weeks.

Intervention type

Supplement

Phase

Not Specified

Drug names

Antioxidant supplementation with high levels of vitamin E and vitamin C

Primary outcome measures

Levels of 'new' parameters of oxidative stress like isofuranes and halogenated phospholipids are determined. Also vascular parameters (fibrinogen, Plasminogen Activator Inhibitor-1 [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 outcome measures

No secondary outcome measures

Overall trial start date

01/01/2002

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Stable (more than six months regarding subjective walking distance) patients with intermittent claudication.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

13

Participant exclusion criteria

1. Patients with pre-existing renal dysfunction
2. Those not able to perform a standard walking test

Recruitment start date

01/01/2002

Recruitment end date

01/04/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Máxima Medical Centre (The Netherlands)

Sponsor details

P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Máxima Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Unilever Research Vlaardingen, Unilever Health Institute (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes