Condition category
Circulatory System
Date applied
15/10/2010
Date assigned
29/10/2010
Last edited
01/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Julie Brittenden

ORCID ID

Contact details

University of Aberdeen
c/o ward 36
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB252ZN
United Kingdom
+44 (0)1224 559 211
j.brittenden@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol v1

Study information

Scientific title

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

Acronym

Study hypothesis

Omega-3 fatty acids are able to reduce the increased platelet and endothelial function that occurs in patients with peripheral arterial disease despite medical therapy and thus may prevent future cardiovascular events.

Ethics approval

Ethics Board of the North East Of Scotland approved in June 2004 (ref: 04/0045)

Study design

Randomised double blind cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Peripheral arterial disease

Intervention

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 washout period of 12 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Omega-3 fatty acid

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/08/2005

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant 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

Recruitment start date

01/08/2005

Recruitment end date

31/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Aberdeen
Aberdeen
AB252ZN
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

c/o Dr E Rattray
Research & Innovation
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
+44 (0)1224 274 369
e.rattray@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK) (ref: PG/04/100/17637)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22296885

Publication citations

  1. Results

    Mackay I, Ford I, Thies F, Fielding S, Bachoo P, Brittenden J, Effect of Omega-3 fatty acid supplementation on markers of platelet and endothelial function in patients with peripheral arterial disease., Atherosclerosis, 2012, 221, 2, 514-520, doi: 10.1016/j.atherosclerosis.2011.12.041.

Additional files

Editorial Notes