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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00192543




Registration number
NCT00192543
Ethics application status
Date submitted
11/09/2005
Date registered
19/09/2005
Date last updated
4/08/2011

Titles & IDs
Public title
The Fish and Fruit Study: Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Scientific title
A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
Secondary ID [1] 0 0
283304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - diet of fish and fruit
BEHAVIORAL - fruit and fish
BEHAVIORAL - diet only
BEHAVIORAL - regular diet

Active comparator: case - diet of fish and fruit addition compared to regular diet

Placebo comparator: control - regular diet


BEHAVIORAL: diet of fish and fruit
fish and fruit in specified quantities

BEHAVIORAL: fruit and fish
no drugs

BEHAVIORAL: diet only
Fish and fruit

BEHAVIORAL: regular diet
no change in regular diet
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Deaths due to cardiovascular disease
Timepoint [1] 0 0
records continue to be checked till 2009
Secondary outcome [1] 0 0
Non-invasive cardiovascular markers: carotid intimal medial thickness
Timepoint [1] 0 0
completed 2008

Eligibility
Key inclusion criteria
* All patients on hemodialysis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Malignancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Department of Health and Community Services - Darwin
Recruitment postcode(s) [1] 0 0
0810 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Northern Territory Government of Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00192543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kerin O'Dea, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00192543