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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

Primary Purpose

Cardiovascular Diseases

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
diet of fish and fruit
fruit and fish
diet only
regular diet
Sponsored by
Menzies School of Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring dialysis, omega-3 fatty acids, antioxidants, cardiovascular markers, Mortality, End-stage renal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients on hemodialysis Exclusion Criteria: Malignancy

Sites / Locations

  • Department of Health and Community Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

case

control

Arm Description

diet of fish and fruit addition compared to regular diet

regular diet

Outcomes

Primary Outcome Measures

Deaths due to cardiovascular disease

Secondary Outcome Measures

Non-invasive cardiovascular markers: carotid intimal medial thickness

Full Information

First Posted
September 11, 2005
Last Updated
August 3, 2011
Sponsor
Menzies School of Health Research
Collaborators
The George Institute, Northern Territory Government of Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00192543
Brief Title
The Fish and Fruit Study: Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Official Title
A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Menzies School of Health Research
Collaborators
The George Institute, Northern Territory Government of Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
dialysis, omega-3 fatty acids, antioxidants, cardiovascular markers, Mortality, End-stage renal disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
case
Arm Type
Active Comparator
Arm Description
diet of fish and fruit addition compared to regular diet
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
regular diet
Intervention Type
Behavioral
Intervention Name(s)
diet of fish and fruit
Other Intervention Name(s)
regular diet
Intervention Description
fish and fruit in specified quantities
Intervention Type
Behavioral
Intervention Name(s)
fruit and fish
Intervention Description
no drugs
Intervention Type
Behavioral
Intervention Name(s)
diet only
Intervention Description
Fish and fruit
Intervention Type
Behavioral
Intervention Name(s)
regular diet
Intervention Description
no change in regular diet
Primary Outcome Measure Information:
Title
Deaths due to cardiovascular disease
Time Frame
records continue to be checked till 2009
Secondary Outcome Measure Information:
Title
Non-invasive cardiovascular markers: carotid intimal medial thickness
Time Frame
completed 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients on hemodialysis Exclusion Criteria: Malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerin O'Dea, PhD
Organizational Affiliation
Menzies School of Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health and Community Services
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
0810
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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