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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: diet of fish and fruit; Behavioral: diet only; Behavioral: fruit and fish; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Northern Territory
    • Darwin, Northern Territory, Australia, 0810
      • Department of Health and Community Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients on hemodialysis

Exclusion Criteria:

• Malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Deaths due to cardiovascular disease	records continue to be checked till 2009

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-invasive cardiovascular markers: carotid intimal medial thickness	completed 2008

Collaborators and Investigators

• Sponsor: Menzies School of Health Research
• Collaborators: The George Institute; Northern Territory Government of Australia
• Investigators: Principal Investigator: Kerin O'Dea, PhD, Menzies School of Health Research

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 11, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): August 4, 2011
• Last Update Submitted That Met QC Criteria: August 3, 2011
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: dialysis; End-stage renal disease; Mortality; antioxidants; omega-3 fatty acids; cardiovascular markers
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 283304