The effect of fish oil on red blood cell function and walking distance in patients with arterial occlusion in the legs

• Conditions: Patients suffering from intermittent claudication; MedDRA version: 16.1Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004342-42-NL
• Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-03
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

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 anticoagulants (coumarin derivatives)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified