Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000996965
Ethics application status
Approved
Date submitted
17/09/2011
Date registered
19/09/2011
Date last updated
19/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can fish oil supplementation improve endothelial function in asymptomatic offspring of patients with peripheral arterial disease?
Scientific title
Can fish oil supplementation improve endothelial function in asymptomatic offspring of patients with peripheral arterial disease?
Secondary ID [1] 263049 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 270782 0
Condition category
Condition code
Cardiovascular 270970 270970 0 0
Diseases of the vasculature and circulation including the lymphatic system
Alternative and Complementary Medicine 270984 270984 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Melrose Omega 18/12 liquid fish oil - AustL93186: ~1.5g EPA and ~1g DHA per 10ml oral daily dose for 12 weeks.
Intervention code [1] 269396 0
Prevention
Intervention code [2] 269404 0
Treatment: Other
Comparator / control treatment
Melrose Omega 18/12 liquid fish oil - AustL93186: ~0.15g EPA and ~0.1g DHA per 10ml oral daily dose for 12 weeks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 279633 0
Endothelium-mediated changes in vascular tone as measured by brachial artery flow-mediated dilatation.
Timepoint [1] 279633 0
Baseline, 6 and 12 weeks.
Secondary outcome [1] 294106 0
Inflammation as measured by CRP, absolute neutrophil and lymphocyte values, TNF-alpha, IL-1 and IL-6.
Timepoint [1] 294106 0
Baseline, 6 and 12 weeks.

Eligibility
Key inclusion criteria
To be included in the study, participants must have a parent with PAD, be aged 18 years and above, have impaired endothelial function and normal ABPI’s.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they (1) ingest 2g or more of total omega 3 daily as per Fish Food Frequency Questionnaire, (2) have a seafood allergy, (3) life expectancy less than 12 weeks, (4) are unable to communicate effectively to provide informed consent, (5) are receiving treatment doses of any antithrombotic agent or (6) receiving dual anti-platelet function drugs (such as aspirin plus clopidogrel or prasugrel or ticlopidine), or (7) are diagnosed with a bleeding disorder such as von Willebrand disease or haemophilia.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes with allocation concealed in aluminium foil will be held by someone not involved in the assessment of eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to groups will be managed by the Flinders University statistician who provides a randomisation service using computerised randomisation software. Allocation will be stratified by PAD of parent (intermittent claudication vs critical limb ischaemia), by fish intake (>2 oily fish meals/week; <2 oily fish meals/week), presence of type 2 diabetes and according to whether the participant is taking anti-hypertensive medication.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4512 0
5042

Funding & Sponsors
Funding source category [1] 269860 0
University
Name [1] 269860 0
Flinders University
Country [1] 269860 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide South Australia 5001
Country
Australia
Secondary sponsor category [1] 268883 0
None
Name [1] 268883 0
Address [1] 268883 0
Country [1] 268883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271833 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 271833 0
Level 2
Flinders Medical Centre
Flinders Drive
Bedford Park South Australia 5042
Ethics committee country [1] 271833 0
Australia
Date submitted for ethics approval [1] 271833 0
Approval date [1] 271833 0
29/08/2011
Ethics approval number [1] 271833 0
HREC 0351.11

Summary
Brief summary
Peripheral Arterial Disease (PAD) is a major public health problem in Australia. The incidence increases with age and an estimated 10-25% of men and women over the age of 55 years are affected. The ageing Australian population will see an increase in the prevalence of PAD and consequently the national annual health expenditure on cardiovascular disease is likely to increase, greatly exceeding the 5.4 billion dollars spent in 2000-01. PAD is preceded by endothelial dysfunction, show an increase in inflammatory markers and failing of the circulation in affected limbs. EPA and DHA have been demonstrated to exert anti-inflammatory effects within the blood vessel wall thus reducing the amount of potent inflammatory markers produced. They also exert anti-thrombotic effects thus increasing the flow of blood within vessels. Dietary supplementation with fish oil rich in n-3 PUFA has been shown to positively impact on vascular function in the setting of atherosclerosis. It is known that there is a heritable basis to PAD, however, little is known whether improvements in endothelial function can be achieved in asymptomatic children of those with established PAD using n-3 PUFA. Early detection and intervention using a non-invasive, readily available, affordable and acceptable supplement such as fish oil has the potential to improve clinical management and prevent or delay the onset of those at high risk of developing symptomatic PAD.

The aim of this study is to implement a 12 week, moderate dose fish oil intervention (10ml/day containing ~1.5g EPA and ~1g DHA), that will result in clinically and statistically significant improvements in terms of:
a) Endothelial function;
b) Inflammation;
c) Lipid status (Total cholesterol, LDL, HDL, TG); and
d) Omega 3 Fatty Acid levels.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33162 0
Address 33162 0
Country 33162 0
Phone 33162 0
Fax 33162 0
Email 33162 0
Contact person for public queries
Name 16409 0
A/Prof Michelle Miller
Address 16409 0
Flinders University Nutrition and Dietetics
Room 7E105.4
Level 7 Flinders Medical Centre
Flinders Drive
Bedford Park South Australia 5042
Country 16409 0
Australia
Phone 16409 0
61 8 82045328
Fax 16409 0
61 8 82046406
Email 16409 0
[email protected]
Contact person for scientific queries
Name 7337 0
A/Prof Michelle Miller
Address 7337 0
Flinders University Nutrition and Dietetics
Room 7E105.4
Level 7 Flinders Medical Centre
Flinders Drive
Bedford Park South Australia 5042
Country 7337 0
Australia
Phone 7337 0
61 8 82045328
Fax 7337 0
61 8 82046406
Email 7337 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.