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The Aboriginal Cardiovascular Omega-3 Randomised Controlled Trial

The effect of omega-3 supplementation on adverse cardiovascular (CV) events among Indigenous Australians with stable coronary artery disease: A randomized controlled trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000732684
Enrollment
89
Registered
2014-07-10
Start date
2015-05-01
Completion date
2017-04-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Heart disease is the single biggest cause of death for Aboriginal and Torres Strait Islander people and the main reason for the difference in life expectancy between Indigenous and non-Indigenous Australians. Indigenous Australians are 3 times more likely to suffer “heart attacks” than non-Indigenous Australians and are 1.5 times more likely to die as a result. Recent studies suggest that Omega 3 polyunsaturated fatty acids (PUFAs) may help prevent “heart attacks” in people who already have coronary artery disease. Coronary artery disease is caused by plaque building up along the inner walls of the arteries of the heart, which narrows the arteries and reduces the blood flow to the heart. Omega 3 oil is a polyunsaturated fatty acid (PUFA) found in some plants, seafood, and, to a lesser extent, eggs and meat. Omega-3 is seen as "essential" because the human body can't produce it and so we must get it from foods or supplements. Several studies around the world have shown a decrease in the risk of sudden cardiac death (SCD) associated with increased consumption of fish or fish oils. This study is likely to be very important for understanding the main cause of death and life expectancy gap for Aboriginal people, as well as providing evidence to guide policy and clinical practice. The purpose of this study is to test the effectiveness of Omega-3 Long Chain Polyunsaturated Fatty Acid supplementation in Aboriginal adults with established coronary artery disease (CAD) to determine effects on factors implicated in adverse cardiovascular (CV) events including: atherogenic and protective lipid factors, Inflammatory factors, factors associated with thrombus formation, arrhythmic risk as measured by heart rate variability, and major adverse cardiovascular events (MACE). The Aboriginal Cardiovascular Omega 3 (AC Omega 3) trial aims to find out if Aboriginal patients who have coronary artery disease will be better protected from having “heart attacks” by taking an Omega 3 oil supplement and if so how does it help do this.

Interventions

Arm 1 a. AlaskOmega® 400200 TG 1000mg (Bioriginal, Nehterlands) (containing 400mg EPA and 200mg DHA per capsule), ensuring the patients receive 1800 mg of n-3 LCPUFA b. softgel oral capsule c. 3 capsules once daily for minimum 6 months All study drugs will be given to participants in a 28-day Webster pack. Participants will have their monthly supply delivered to them (at home or clinic) by a member of the clinical team. The study participant will be asked to return the used and unused contai

Arm 1 a. AlaskOmega® 400200 TG 1000mg (Bioriginal, Nehterlands) (containing 400mg EPA and 200mg DHA per capsule), ensuring the patients receive 1800 mg of n-3 LCPUFA b. softgel oral capsule c. 3 capsules once daily for minimum 6 months All study drugs will be given to participants in a 28-day Webster pack. Participants will have their monthly supply delivered to them (at home or clinic) by a member of the clinical team. The study participant will be asked to return the used and unused containers at each visit. Accountability of IP consumption will be evaluated by a member of the clinical team through subject interview and the counting of unused study drug. Compliance (percent) = (the number consumed) ÷ (the number prescribed) x 100. Lost or discarded IP should not be included in the calculation. This information will be recorded on a standard reporting form and monitored across the program. If compliance is less than 80%, subjects will receive additional instructions about treatment regimens.

Sponsors

South Australian Health and Medical Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men or women, self-identified as Indigenous * Aged over 18 years * Have confirmed Coronary Artery Disease [CAD] (according to nationally consistent definitions): * Prior hospitalisation for myocardial infarction/acute coronary syndrome * Prior revascularisation * Proven coronary stenosis >50%

Exclusion criteria

* Non-residents of South Australia or Alice Springs, NT. * Patients with significant neurological/cognitive impairment that prevents consent * Hypersensitivity or documented allergy to the study drug * Known bleeding disorder or end-stage renal disease requiring dialysis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026