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

ISRCTN	ISRCTN69086952
DOI	https://doi.org/10.1186/ISRCTN69086952
Secondary identifying numbers	METC 0114/0112 X, NL353 (NTR392)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof H L Vader
Scientific

P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Phone	+31 (0)40 888 8900
Email	h.vader@mmc.nl

Study design	Crossover feasability study
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Other
Study type	Treatment
Scientific title	Feasibility study to use new techniques/biomarkers to measure oxidative stress and the influence of vitamin E and C on these parameters in patients suffering from intermittent claudication
Study objectives	Multivariate Nuclear Magnetic Resonance (NMR) can be used to measure oxidative stress in patients suffering from intermittent claudication.
Ethics approval(s)	Approval received by the Medical Ethical Review Board of Máxima Medical Centre in Eindhoven/Veldhoven on October 2, 2001 (ref: METC 0114).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2002
Completion date	01/04/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	13
Total final enrolment	17
Key inclusion criteria	Stable (more than six months regarding subjective walking distance) patients with intermittent claudication.
Key exclusion criteria	1. Patients with pre-existing renal dysfunction 2. Those not able to perform a standard walking test
Date of first enrolment	01/01/2002
Date of final enrolment	01/04/2004

P.O. Box 7777

Veldhoven
5500 MB
Netherlands

Máxima Medical Centre (The Netherlands)
Hospital/treatment centre

P.O. Box 7777
Veldhoven
5500 MB
Netherlands

"ROR"	https://ror.org/02x6rcb77

Industry

Máxima Medical Centre (The Netherlands)

No information available

Unilever Research Vlaardingen, Unilever Health Institute (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/08/2008	26/03/2021	Yes	No

26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.