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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
Assessment method [1] 0 0
Timepoint [1] 0 0
records continue to be checked till 2009
Secondary outcome [1] 0 0
Non-invasive cardiovascular markers: carotid intimal medial thickness
Assessment method [1] 0 0
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Northern Territory Government of Australia
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00192543