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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192543
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 4, 2011
The George Institute
Northern Territory Government of Australia
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: diet of fish and fruit Behavioral: fruit and fish Behavioral: diet only Behavioral: regular diet Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Study Start Date : May 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: case
diet of fish and fruit addition compared to regular diet
Behavioral: diet of fish and fruit
fish and fruit in specified quantities
Other Name: regular diet
Behavioral: diet only
Fish and fruit
Placebo Comparator: control
regular diet
Behavioral: fruit and fish
no drugs
Behavioral: regular diet
no change in regular diet

Primary Outcome Measures :
  1. Deaths due to cardiovascular disease [ Time Frame: records continue to be checked till 2009 ]

Secondary Outcome Measures :
  1. Non-invasive cardiovascular markers: carotid intimal medial thickness [ Time Frame: completed 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients on hemodialysis

Exclusion Criteria:

  • Malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192543

Australia, Northern Territory
Department of Health and Community Services
Darwin, Northern Territory, Australia, 0810
Sponsors and Collaborators
Menzies School of Health Research
The George Institute
Northern Territory Government of Australia
Principal Investigator: Kerin O'Dea, PhD Menzies School of Health Research

Responsible Party: Gurmeet Singh, Menzies School of Health Research Identifier: NCT00192543     History of Changes
Other Study ID Numbers: 283304
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: March 2009

Keywords provided by Menzies School of Health Research:
omega-3 fatty acids
cardiovascular markers
End-stage renal disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency