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The Fish and Fruit Study: Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease

A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00192543
Enrollment
152
Registered
2005-09-19
Start date
2004-05-31
Completion date
2008-12-31
Last updated
2011-08-04

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

Conditions

Cardiovascular Diseases

Keywords

dialysis, omega-3 fatty acids, antioxidants, cardiovascular markers, Mortality, End-stage renal disease

Brief summary

Cardiovascular disease is the main cause of death in patients on dialysis for end stage renal disease. Omega-3 fatty acids and antioxidants have been shown to be protective in the general population. A diet of fish and fruit, which will provide the fatty acids and the antioxidants is being tried in dialysis patients to assess the effect on cardiovascular disease in this high risk group.

Detailed description

End stage renal disease (ESRD) is a devastating disease which affects Aboriginal Australians disproportionately: The average survival time for Aboriginal people in the Northern Territory is 3.6 years from the onset of kidney failure, compared to 12.3 years for non-Aboriginal people. There has been a dramatic rise in incidence of kidney failure over the past 20 years, with the prevalence doubling every 4-5 years in many NT communities and other remote parts of Australia. Mortality for patients with ESRD is approximately 5 to 10 fold that of the general population, with heart disease accounting for approximately half of deaths. The aims of this study are to determine whether a dietary intervention of fish and fruit three times a week will decrease cardiovascular and all-cause mortality in patients on haemodialysis in Darwin and Alice Springs . There is a strong scientific rationale for this simple dietary intervention. Fish are a rich source of omega-3 fatty acids, believed to reduce the risk of heart attack. Fruit is a good source of anti oxidants and other chemicals that may amplify the beneficial effects of fish. Participants are randomized to either control and intervention groups according to their regular days of dialysis. Nutritional and cardiovascular status will be measured at commencement of the study and then at intervals of 3, 6 and 12 months. Strategies have been incorporated into the project design to ensure understanding, informed consent and participation of Aboriginal people in a number of domains: the participant, their family, urban and remote communities, and service providers. If successful this intervention will result in changes to the clinical management of renal patients worldwide.

Interventions

BEHAVIORALdiet of fish and fruit

fish and fruit in specified quantities

BEHAVIORALfruit and fish

no drugs

BEHAVIORALdiet only

Fish and fruit

BEHAVIORALregular diet

no change in regular diet

Sponsors

The George Institute
CollaboratorOTHER
Northern Territory Government of Australia
CollaboratorOTHER_GOV
Menzies School of Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

Inclusion criteria

* All patients on hemodialysis

Exclusion criteria

* Malignancy

Design outcomes

Primary

MeasureTime frame
Deaths due to cardiovascular diseaserecords continue to be checked till 2009

Secondary

MeasureTime frame
Non-invasive cardiovascular markers: carotid intimal medial thicknesscompleted 2008

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026