Omega-3 fatty acids on platelet and endothelial function in patients with peripheral arterial disease
| ISRCTN | ISRCTN54802970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54802970 |
| Protocol serial number | Protocol v1 |
| Sponsor | University of Aberdeen (UK) |
| Funder | British Heart Foundation (BHF) (UK) (ref: PG/04/100/17637) |
- Submission date
- 15/10/2010
- Registration date
- 29/10/2010
- Last edited
- 01/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Aberdeen
c/o ward 36
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB252ZN
United Kingdom
| Phone | +44 (0)1224 559 211 |
|---|---|
| j.brittenden@abdn.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind cross-over trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of omega-3 fatty acids on platelet and endothelial function in patients with peripheral arterial disease |
| Study objectives | 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(s) | Ethics Board of the North East Of Scotland approved in June 2004 (ref: 04/0045) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Omega-3 fatty acid |
| Primary outcome measure(s) |
In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on: |
| Key secondary outcome measure(s) |
In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 150 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
AB252ZN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
