Omega-3 fatty acids on platelet and endothelial function in patients with peripheral arterial disease
| ISRCTN | ISRCTN54802970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54802970 |
| Secondary identifying numbers | Protocol v1 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Julie Brittenden
Scientific
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
| Study design | Randomised double blind cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omega-3 fatty acid |
| Primary outcome measure | 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 study start date | 01/08/2005 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
University of Aberdeen
Aberdeen
AB252ZN
United Kingdom
AB252ZN
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
c/o Dr E Rattray
Research & Innovation
Polwarth Building, Foresterhill
Aberdeen
AB25 2ZN
Scotland
United Kingdom
| Phone | +44 (0)1224 274 369 |
|---|---|
| e.rattray@abdn.ac.uk | |
| Website | http://www.abdn.ac.uk/ |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK) (ref: PG/04/100/17637)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
