Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192543
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2005-09-11
Brief Title:
The Fish and Fruit Study Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Sponsor:
Menzies School of Health Research
Organization:
Menzies School of Health Research
Study Overview
Official Title:
A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 36 years from the onset of kidney failure compared to 123 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None