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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

This study has been completed.
Sponsor:
Collaborators:
The George Institute
Department of Health and Community Services, NT, Australia
Information provided by:
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT00192543
First received: September 11, 2005
Last updated: August 3, 2011
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Cardiovascular Diseases
 Behavioral: diet of fish and fruit
Behavioral: fruit and fish
Behavioral: diet only
Behavioral: regular diet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • Deaths due to cardiovascular disease [ Time Frame: records continue to be checked till 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-invasive cardiovascular markers: carotid intimal medial thickness [ Time Frame: completed 2008 ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: May 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients on hemodialysis

Exclusion Criteria:

  • Malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192543

Locations
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
Department of Health and Community Services, NT, Australia
Investigators
Principal Investigator: Kerin O'Dea, PhD Menzies School of Health Research
  More Information

No publications provided

Responsible Party: Gurmeet Singh, Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT00192543     History of Changes
Other Study ID Numbers: 283304
Study First Received: September 11, 2005
Last Updated: August 3, 2011
Health Authority: Australia: National Health and Medical Research Council

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

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

ClinicalTrials.gov processed this record on May 21, 2013