- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00192543
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Northern Territory
-
Darwin, Northern Territory, Australia, 0810
- Department of Health and Community Services
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All patients on hemodialysis
Exclusion Criteria:
- Malignancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: case
diet of fish and fruit addition compared to regular diet
|
fish and fruit in specified quantities
Andre navn:
Fish and fruit
|
|
Placebo komparator: control
regular diet
|
no drugs
no change in regular diet
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Deaths due to cardiovascular disease
Tidsramme: records continue to be checked till 2009
|
records continue to be checked till 2009
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Non-invasive cardiovascular markers: carotid intimal medial thickness
Tidsramme: completed 2008
|
completed 2008
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Kerin O'Dea, PhD, Menzies School of Health Research
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 283304
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