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

Phase 3

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: diet of fish and fruit; Behavioral: fruit and fish; Behavioral: diet only; Behavioral: regular diet

• Registration Number: NCT00192543
• Lead Sponsor: Menzies School of Health Research

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• All patients on hemodialysis

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Exclusion Criteria

• Malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
case	diet of fish and fruit	diet of fish and fruit addition compared to regular diet
case	diet only	diet of fish and fruit addition compared to regular diet
control	fruit and fish	regular diet
control	regular diet	regular diet

Primary Outcome Measures

Name	Time	Method
Deaths due to cardiovascular disease	records continue to be checked till 2009

Secondary Outcome Measures

Name	Time	Method
Non-invasive cardiovascular markers: carotid intimal medial thickness	completed 2008

Trial Locations

Locations (1)

Department of Health and Community Services; 🇦🇺 Darwin, Northern Territory, Australia