Clinical Trial Results:
A randomised control trial of omega-3 fatty acid on platelet and endothelial function in patients with peripheral arterial disease
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Summary
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EudraCT number |
2005-001332-69 |
Trial protocol |
GB |
Global end of trial date |
31 Jul 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Aug 2018
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First version publication date |
19 Aug 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PG/04/100/17637
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Additional study identifiers
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ISRCTN number |
ISRCTN54802970 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Aberdeen
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Sponsor organisation address |
Research & Innovation, Polwarth Building, Foresterhill, , Aberdeen, United Kingdom,
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Public contact |
Dr E Rattray, University of Aberdeen , 01224 551123, researchgovernance@abdn.ac.uk
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Scientific contact |
Dr Shona Fielding, University of Aberdeen, 01224 551123, researchgovernance@abdn.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jan 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jul 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jul 2007
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
In patients with peripheral arterial disease, to assess the effects of omega-3 fatty acids on
1) platelet function
2) markers of endothelial activation
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Protection of trial subjects |
Ethical approval was obtained from the local research ethics committee and written informed consent was obtained from each patient.
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Background therapy |
150 patients who were receiving aspirin and statin therapy were recruited into a randomised cross-over double blind study involving 6 week supplementation with OMACOR fish oil versus placebo. A 12 week washout period occurred between treatments. | ||
Evidence for comparator |
Placebo - an 80:20 blend of palm and soya bean oils, which closely match that of the average adult UK diet (British Nutrition Foundation, 1992). | ||
Actual start date of recruitment |
01 Aug 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 150
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Worldwide total number of subjects |
150
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EEA total number of subjects |
150
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
51
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From 65 to 84 years |
97
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85 years and over |
2
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Recruitment
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Recruitment details |
150 consecutive patients with history of stable IC & clinical findings of peripheral vascular disease were recruited over 2 year period. Patients identified at claudication clinic & from clinic database. Patients co-morbidity, cardiovascular medication & ankle brachial pressure indices were documented. | |||||||||
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Pre-assignment
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Screening details |
Eligible if their ankle brachial pressure index was less that 0.8 & they were receiving statin & aspirin therapy. | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
The placebo & supplement were indistinguishable & independently packaged by the Pharmacy Dept of Glasgow Western Infirmary. Pharmacists dispensed placebo or active drug packs according to a computer generated randomisation process. The code was held by the Trial Drugs Pharmacy Dept & was only revealed to the researchers once recruitment, data collection & lab analysis were complete.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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OMACOR | |||||||||
Arm description |
850-882mg Eicoapentaenoic acid Docosahexaenoic acid | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
OMACOR
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Six weeks of OMACOR supplementation followed by 12 weeks washout followed by six weeks of placebo
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Arm title
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Placebo | |||||||||
Arm description |
80:20 blend of palm and soybean oils. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Six weeks of placebo followed 12 week washout followed by six weeks of OMACOR supplementation.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
OMACOR
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Reporting group description |
850-882mg Eicoapentaenoic acid Docosahexaenoic acid | ||
Reporting group title |
Placebo
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Reporting group description |
80:20 blend of palm and soybean oils. | ||
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End point title |
Von Willebrand factor antigen (vWF) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 weeks
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Statistical analysis title |
Intention to treat | ||||||||||||
Statistical analysis description |
Data was analysed on an intention to treat basis and study findings reported in line with CONSORT.
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Comparison groups |
OMACOR v Placebo
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Number of subjects included in analysis |
150
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Within 24hrs
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
None | ||
Dictionary version |
0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No Non-serious Adverse Events were recorded. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/22296885 |
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