The effect of fish oil supplements during supervised exercise therapy in patients with intermittent claudicatio

Phase 3

Completed

Conditions: intermittent claudication
peripheral arterial disease
10003216

Registration Number: NL-OMON40369

Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 136

Inclusion Criteria

*Age * 18
*Newly diagnosed intermittent claudication
*Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise
*Able to perform standardized treadmill walking test for 2 min
*Written informed consent

Exclusion Criteria

*Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
*Heart failure or unstable cardiac status (angina pectoris NYHA class III or IV or recent myocardial infarction < 3 months)
*Any illness with rapid evolution or a life expectancy < 3 months
*Recent cerebrovascular accident (< 3 months)
*Current use of fish oil supplements or > 2 times a week dietary fish
*Pregnancy
*Fish, soybean or peanut allergy
*Contra indications for the use of omega-3 fatty acids
- Use of oral anti-coagulants (coumarin derivatives)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in maximal walking distance after 12<br /><br>weeks of SET. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are hemorheological parameters: erythrocyte<br /><br>deformability and aggregation, blood and plasma viscosity and clinical outcome<br /><br>parameters: change in pain free walking distance, Ankle Brachial Index, blood<br /><br>pressure and heart rate, perceived walking impairment, visceral fat mass,<br /><br>sublingual microcirculation, laboratory measures of total, HDL- and LDL<br /><br>cholesterol and triglycerides, erythrocyte membrane fatty acid compositon, and<br /><br>ex vivo whole blood cytokine production after stimulation with LPS. </p><br>