Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000483459
Ethics application status
Approved
Date submitted
10/04/2016
Date registered
13/04/2016
Date last updated
2/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of omega-3 fatty acids on inflammation and blood vessel function in abdominal aortic aneurysm
Scientific title
Investigation of the efficacy of inflammatory biomarkers and vascular function in patients with abdominal aortic aneurysm treated with omega-3 polyunsaturated fatty acids
Secondary ID [1] 288953 0
Wishlist Foundation 2014-04
Universal Trial Number (UTN)
U1111-1181-7313
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal aortic aneurysm 298333 0
Condition category
Condition code
Cardiovascular 298451 298451 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily oral administration of 1.8 g omega-3 fatty acid capsules (composition: eicosapentaenoic acid, 0.3 g; docosahexaenoic acid, 1.5 g), or equivolume of placebo for a duration of 12 weeks. Adherence will be measured by returned capsule count and analysis of cell membrane phospholipid fatty acid incorporation using GC-MS.
Intervention code [1] 294439 0
Treatment: Other
Comparator / control treatment
Placebo capsules of the same size as the active. Placebo capsules will contain a small amount of fish oil.
Control group
Placebo

Outcomes
Primary outcome [1] 297938 0
Concentration of blood and urine biomarkers of inflammation and oxidative stress as a composite outcome (includes 8-isoprostane, interleukin (IL)-1, 6 and 10, tumour necrosis factor alpha, and expression levels and activity of antioxidant enzymes (catalase, heme oxygenase, glutathione peroxidase, superoxide dismutase). Studies will use GC-MS, commercially available ELISAs, commercially available activity assay kits, and Western blots using commercially available antibodies.
Timepoint [1] 297938 0
Measured at baseline, and at 3 and 12 weeks after commencement of dietary supplementation.
Primary outcome [2] 297939 0
Indices of vascular stiffness and vessel structure, including intima-media thickness at the carotid artery, augmentation index and pulse wave velocity, This is a composite outcome measured using B-mode ultrasound and SphygmoCor XCEL automated blood pressure device,
Timepoint [2] 297939 0
Measured at baseline, and at 3 and 12 weeks after commencement of dietary supplementation.
Primary outcome [3] 297971 0
Flow-mediated dilation measured using non-invasive Doppler ultrasound.
Timepoint [3] 297971 0
Measured at baseline, and at 3 and 12 weeks after commencement of dietary supplementation.
Secondary outcome [1] 322685 0
Blood pressure measurements using a SphygmoCor XCEL automated blood pressure device.
Timepoint [1] 322685 0
Measured at baseline and 3 and 12 weeks after commencement of dietary supplementation.

Eligibility
Key inclusion criteria
Participants will be included if they are between 55-86 years of age, male or female, smoker or non-smoker. All participants will have small AAA (3.0-4.9 cm maximal diameter, measured using ultrasound or CT). Participants must have the capacity to understand instructions, for example the procedures to be followed for capsule supplementation.
Minimum age
55 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude participants if they i) report a usual dietary intake of more than 2 oily fish meals per week, ii) report the use of fish oil or krill oil supplements iii) report the use of anti-inflammatory medications, iv) report an imminent surgical procedure, v) have cognitive impairment that presents a risk that instructions will not be followed accurately vi) the prospective participant's treating physician deems them unsuitable for the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization using a computer. Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of participants will be carried out using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
n=20 participants per group will be required for this study. We will recruit a total of 25 AAA patients to the treatment group and 25 AAA patients to the placebo group, allowing for 20% attrition over the course of the 12 week treatment period.
Preliminary analyses of biomarkers of inflammation and oxidative stress using blood samples from a related project that has recruited patients with small AAA. Using this pilot data, we have carried out power analyses to determine the number of participants that are required for this trial.
8-Isoprostane: In AAA participants, 8-isoprostane concentration was 52.0 pg/ml (SEM, 3.5, n=10). To detect a decrease in 8-isoprostane concentration by 10 pg/ml (to 42.0 pg/ml) with Power of 0.80 and significance level 0.05 (two-sided), 20 participants need to be recruited to the treatment group and 20 participants to the placebo group (total 40 participants). For comparison, we measured 8-isoprostane levels in non-AAA participants and found the levels to be 17.5 pg/ml lower than in AAA participants (34.5 pg/ml; SEM=2.5, n=28).
Catalase activity: In AAA participants, catalase activity was 70.0 nmol/min/ml (SEM, 9.7, n=10). To detect an increase in catalase activity by 30 nmol/min/ml (to 100.0 nmol/min/ml) with Power of 0.80 and significance level 0.05 (two sided), 18 participants need to be recruited to the treatment group and 18 participants to the placebo group (total 36 participants). For comparison, we measured catalase activity in non-AAA participants and found the levels to be 46.0 nmol/min/ml higher than in AAA participants (116.0 nmol/min/ml; SEM=9.2, n=28).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2016
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5586 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 13039 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 293312 0
Charities/Societies/Foundations
Name [1] 293312 0
Wishlist Foundation
Country [1] 293312 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
90 Sippy Downs Drive
Sippy Downs
Queensland 4556
Australia
Country
Australia
Secondary sponsor category [1] 292125 0
None
Name [1] 292125 0
None
Address [1] 292125 0
None
Country [1] 292125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294786 0
The Prince Charles Hospital
Ethics committee address [1] 294786 0
Ethics committee country [1] 294786 0
Australia
Date submitted for ethics approval [1] 294786 0
14/04/2016
Approval date [1] 294786 0
17/05/2016
Ethics approval number [1] 294786 0
HREC/16/QPCH/114
Ethics committee name [2] 294787 0
University of the Sunshine Coast
Ethics committee address [2] 294787 0
Ethics committee country [2] 294787 0
Australia
Date submitted for ethics approval [2] 294787 0
18/04/2016
Approval date [2] 294787 0
Ethics approval number [2] 294787 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65030 0
Dr Fraser Russell
Address 65030 0
School of Health and Sport Sciences,
University of the Sunshine Coast,
90 Sippy Downs Drive,
Sippy Downs 4556, Queensland.
Country 65030 0
Australia
Phone 65030 0
+61 7 5459 4665
Fax 65030 0
Email 65030 0
[email protected]
Contact person for public queries
Name 65031 0
Fraser Russell
Address 65031 0
School of Health and Sport Sciences,
University of the Sunshine Coast,
90 Sippy Downs Drive,
Sippy Downs 4556, Queensland.
Country 65031 0
Australia
Phone 65031 0
+61 7 5459 4665
Fax 65031 0
Email 65031 0
[email protected]
Contact person for scientific queries
Name 65032 0
Fraser Russell
Address 65032 0
School of Health and Sport Sciences,
University of the Sunshine Coast,
90 Sippy Downs Drive,
Sippy Downs 4556, Queensland.
Country 65032 0
Australia
Phone 65032 0
+61 7 5459 4665
Fax 65032 0
Email 65032 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
SourceTitleYear of PublicationDOI
EmbaseN-3 PUFAs improve erythrocyte fatty acid profile in patients with small AAA: A randomized controlled trial.2019https://dx.doi.org/10.1194/jlr.P093013
N.B. These documents automatically identified may not have been verified by the study sponsor.