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

September 11, 2005
August 3, 2011
May 2004
December 2008   (final data collection date for primary outcome measure)
Deaths due to cardiovascular disease [ Time Frame: records continue to be checked till 2009 ] [ Designated as safety issue: No ]
Deaths due to cardiovascular disease
Complete list of historical versions of study NCT00192543 on ClinicalTrials.gov Archive Site
Non-invasive cardiovascular markers: carotid intimal medial thickness [ Time Frame: completed 2008 ] [ Designated as safety issue: No ]
  • Non-invasive cardiovascular markers:
  • Carotid Intimal Media thickness
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Diseases
  • Behavioral: diet of fish and fruit
    fish and fruit in specified quantities
    Other Name: regular diet
  • Behavioral: fruit and fish
    no drugs
  • Behavioral: diet only
    Fish and fruit
  • Behavioral: regular diet
    no change in regular diet
  • Active Comparator: case
    diet of fish and fruit addition compared to regular diet
    Interventions:
    • Behavioral: diet of fish and fruit
    • Behavioral: diet only
  • Placebo Comparator: control
    regular diet
    Interventions:
    • Behavioral: fruit and fish
    • Behavioral: regular diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients on hemodialysis

Exclusion Criteria:

  • Malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00192543
283304
No
Gurmeet Singh, Menzies School of Health Research
Menzies School of Health Research
  • The George Institute
  • Department of Health and Community Services, NT, Australia
Principal Investigator: Kerin O'Dea, PhD Menzies School of Health Research
Menzies School of Health Research
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP