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Study 2 of 11 for search of: | Australia, Northern Territory |
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Sponsors and Collaborators: |
Menzies School of Health Research The George Institute, Sydney , Australia Department of Health and Community Services, NT, Australia |
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Information provided by: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT00192543 |
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 trialled in dialysis patients to assess the effect on cardiovascular disease in this high risk group.
Condition | Intervention | Phase |
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Cardiovascular Diseases |
Behavioral: diet of fish and fruit |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease |
Estimated Enrollment: | 150 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Northern Territory | |
Department of Health and Community Services | |
Darwin, Northern Territory, Australia, 0810 |
Principal Investigator: | Kerin O'Dea, PhD | Menzies School of Health Research |
Study ID Numbers: | 283304 |
Study First Received: | September 11, 2005 |
Last Updated: | October 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00192543 |
Health Authority: | Australia: National Health and Medical Research Council |
dialysis omega-3 fatty acids antioxidants |
cardiovascular markers Mortality End-stage renal disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Cardiovascular Diseases |