Omega-3 fatty acids on platelet and endothelial function in patients with peripheral arterial disease

A randomised controlled trial of omega-3 fatty acids on platelet and endothelial function in patients with peripheral arterial disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54802970

Enrollment

150

Registered

2010-10-29

Start date

2005-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease Circulatory System Peripheral arterial disease

Interventions

OMACOR fish oil (850 - 882 mg eicosapentaenoic acid and docosahexaenoic acid) (intervention) or placebo (an 80:20 blend of palm and soybean oils) (control). Supplementation will be for 6 weeks, with a

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Able to give informed consent 2. Have an ankle brachial pressure index (ABPI) less than 0.8 3. On a statin and aspirin 4. Must be able to attend the nurse-led claudication clinic 5. Aged 35 - 90 years, either sex Strict attention will be paid to secondary risk factor prevention as per our local guidelines. These include measures to achieve the target blood pressure (less than 140/85 mmHg), screening for diabetes, referral to smoking cessation clinic, nicotine replacement therapy and advice on exercise.

Exclusion criteria

Exclusion criteria: 1. Rest pain or ulceration, liver impairment or abnormal platelet count or diabetes 2. On clopidogrel, warfarin or non-steroidal anti-inflammatory drugs

Design outcomes

Primary

Measure	Time frame
In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on: 1. Platelet function 2. Markers of endothelial activation Primary and secondary timepoints are measured at baseline, immediately following 6 weeks of active/placebo treatment, 12 weeks later following washout period and prior to commencing placebo/active treatment, and at the end of 6 weeks of placebo/active treatment.	—

Measure

Time frame

In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on: 1. Platelet function 2. Markers of endothelial activation Primary and secondary timepoints are measured at baseline, immediately following 6 weeks of active/placebo treatment, 12 weeks later following washout period and prior to commencing placebo/active treatment, and at the end of 6 weeks of placebo/active treatment.

—

Secondary

Measure	Time frame
In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on markers of inflammation. Primary and secondary timepoints are measured at baseline, immediately following 6 weeks of active/placebo treatment, 12 weeks later following washout period and prior to commencing placebo/active treatment, and at the end of 6 weeks of placebo/active treatment.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026