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Completed

NCT Number: NCT00192543

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients on hemodialysis

Exclusion criteria

  • Malignancy

Treatment and study plan

diet of fish and fruit

Behavioral

fish and fruit in specified quantities

Other names: regular diet

fruit and fish

Behavioral

no drugs

Diet only

Behavioral

Fish and fruit

Regular diet

Behavioral

no change in regular diet

Primary outcomes

  1. Deaths due to cardiovascular disease

    Time frame: records continue to be checked till 2009

Secondary outcomes

  1. Non-invasive cardiovascular markers: carotid intimal medial thickness

    Time frame: completed 2008

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

  • Northern Territory Government of Australia
  • The George Institute

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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