Patients suffering from intermittent claudication MedDRA version: 16.1 Level: LLT Classification code 10067825 Term: Peripheral arterial disease System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Omega-3 fatty acid ethylesthers
Product Name: Omega-3 fatty acid ethylesthers
Pharmaceutical Form: Capsule, soft
Sponsors
Medisch Centrum Alkmaar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age = 18 •Newly diagnosed intermittent claudication •Ankle Brachial Index 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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of omega-3 fatty acids on maximal walking distance in patients with intermittent claudication (IC) receiving supervised exercise therapy (SET) compared to patients with IC receiving SET alone. ;Secondary Objective: To study the effect of supplementation of omega-3 fatty acids during 4 weeks on: - Hemorheological parameters: blood and plasma viscosity, hematocrit and erythrocyte deformability and aggregation - Pain free walking distance -Ankle Brachial Index -- Blood values (Hemoglobin, leucocytes, CRP, total-, HDL- and LDLcholesterol, triglycerides)-Blood pressure and heart rate -Walking impairment measured by questionnaire - ex vivo cytokine production of IL-6, IL-10 and TNF-alpha of whole blood stimulated with LPS - Erythrocyte membrane fatty acid composition - Visceral fat mass To compare treatment with SET and omega-3 fatty acids to treatment with SET alone by determining the above metioned parameters. ;Primary end point(s): The main study parameter is the change in maximal walking distance after 12 weeks of exercise therapy. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Hemorheological parameters: blood and plasma viscosity, hematocrit and erythrocyte deformability and aggregation •Pain free walking distance •Maximal walking distance •Ankle Brachial Index •Other laboratory measures: hemoglobin, leucocytes, CRP, total-, LDL-, and HDL cholesterol, triglycerides •Blood pressure and heart rate •Walking impairment measured by questionnaire - erythrocyte membrane fatty acid composition - ex vivo LPS stimulated whole blood cytokine production - visceral fat mass;Timepoint(s) of evaluation of this end point: Intervention group: baseline, 4 weeks, 10 weeks, 16 weeks Control group: baseline, 6 weeks, 12 weeks | — |
Countries
Netherlands
Contacts
Public ContactAlexander Houdijk
Medisch Centrum Alkmaar
Outcome results
None listed