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 |
| Protocol serial number | METC 0114/0112 X, NL353 (NTR392) |
| Sponsor | Máxima Medical Centre (The Netherlands) |
| Funders | Máxima Medical Centre (The Netherlands), Unilever Research Vlaardingen, Unilever Health Institute (The Netherlands) |
- Submission date
- 23/02/2007
- Registration date
- 23/02/2007
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof H L Vader
Scientific
Scientific
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
| Phone | +31 (0)40 888 8900 |
|---|---|
| h.vader@mmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Crossover feasability study |
| Secondary study design | Single-centre |
| 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(s) | 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. |
| Key secondary outcome measure(s) | No secondary outcome measures |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
5500 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2008 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
