ANZCTR - Registration

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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]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peripheral Arterial Disease

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Alternative and Complementary Medicine

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]

Prevention

Intervention code [2]

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]

Endothelium-mediated changes in vascular tone as measured by brachial artery flow-mediated dilatation.

Timepoint [1]

Baseline, 6 and 12 weeks.

Secondary outcome [1]

Inflammation as measured by CRP, absolute neutrophil and lymphocyte values, TNF-alpha, IL-1 and IL-6.

Timepoint [1]

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?

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]

5042

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

GPO Box 2100
Adelaide South Australia 5001

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

GPO Box 2100
Adelaide South Australia 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Level 2
Flinders Medical Centre
Flinders Drive
Bedford Park South Australia 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/08/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

A/Prof Michelle Miller

Address

Flinders University Nutrition and Dietetics
Room 7E105.4
Level 7 Flinders Medical Centre
Flinders Drive
Bedford Park South Australia 5042

Country

Australia

Phone

61 8 82045328

Fax

61 8 82046406

michelle.miller@flinders.edu.au

Contact person for scientific queries

Name

A/Prof Michelle Miller

Address

Flinders University Nutrition and Dietetics
Room 7E105.4
Level 7 Flinders Medical Centre
Flinders Drive
Bedford Park South Australia 5042

Country

Australia

Phone

61 8 82045328

Fax

61 8 82046406

michelle.miller@flinders.edu.au

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.

Trial Review

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