Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000455460
Ethics application status
Approved
Date submitted
30/08/2007
Date registered
10/09/2007
Date last updated
10/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish oils in chronic kidney disease
Scientific title
A 12 week intervention examining the effect of fish oil on appetite, inflammatory markers and nutritional parameters in dialysis patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease 2310 0
Condition category
Condition code
Renal and Urogenital 2411 2411 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants are given a fish oil supplement containing 2g Eicosapentaenoic Acid (EPA) per day for 12 weeks (capsules or oil, participants choice). All outcomes (appetite, inflammatory, nutritional, quality of life) are measured at baseline and 12 weeks. Appetite also measured at wk 4 and wk 12. Participants consent to pre-baseline data being used as historical control.
Intervention code [1] 2032 0
Treatment: Other
Comparator / control treatment
The control will be historial control. The consent process will involve participants consenting that data from routine care can be used in analysis. Data from 12 weeks prior to baseline accessed from medical records.
Control group
Historical

Outcomes
Primary outcome [1] 3310 0
Appetite, measured by: 1) Rating appetite on a Likert scale 2) Rating appetite on a visual analog scale, plus 3) blood markers (leptin, ghrelin, peptide YY, glucopeptide-1).
Timepoint [1] 3310 0
Pre-baseline, baseline, week4, week 8 and week 12.
Secondary outcome [1] 5515 0
Inflammation, measured by the following markers: 1) Interleukin 6, 2) C-reactive protein 3) Adhesion molecules 4) White cell count.
Timepoint [1] 5515 0
Prebaseline, baseline and week 12.
Secondary outcome [2] 5516 0
Quality of Life, measured by the Kidney Disease Quality of Life questionnaire.
Timepoint [2] 5516 0
Baseline and week 12
Secondary outcome [3] 5517 0
Dietary Intake, measured by 3-day food record kept by the participants which will later be reviewed by the trial's research staff and analysed using Foodworks ver 3.0 (Xyris software).
Timepoint [3] 5517 0
Prebaseline, baseline and week 12

Eligibility
Key inclusion criteria
Adult chronic kidney disease patients aged > 18 years who have been receiving hemodialysis for > 3 months.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking a fish oil supplement providing > 500 mg/day, aged < 18 years, on hemodialysis < 3 months, presence of emotional, cognitive or language limitations impairing their ability to provide informed consent or follow study instructions (where a carer or translator is not available).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 422 0
4066

Funding & Sponsors
Funding source category [1] 2571 0
University
Name [1] 2571 0
Queensland University of Technology
Country [1] 2571 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Faculty of Health
Kelvin Grove Campus
Victoria Park Road
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 2325 0
Hospital
Name [1] 2325 0
The Wesley Hospital
Address [1] 2325 0
451 Coronation Drive
Auchenflower QLD 4066
Country [1] 2325 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4491 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 4491 0
Ethics committee country [1] 4491 0
Australia
Date submitted for ethics approval [1] 4491 0
12/09/2006
Approval date [1] 4491 0
18/12/2006
Ethics approval number [1] 4491 0
0600000589

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28017 0
Address 28017 0
Country 28017 0
Phone 28017 0
Fax 28017 0
Email 28017 0
Contact person for public queries
Name 11174 0
Rachel Zabel
Address 11174 0
Institute of Health and Biomedical Innovation (IHBI)
Cnr Musk Ave and Blamey Street
Kelvin Grove QLD 4059
Country 11174 0
Australia
Phone 11174 0
+61 7 31386134
Fax 11174 0
Email 11174 0
r.zabel@qut.edu.au
Contact person for scientific queries
Name 2102 0
Rachel Zabel
Address 2102 0
Institute of Health and Biomedical Innovation (IHBI)
Cnr Musk Ave and Blamey Street
Kelvin Grove QLD 4059
Country 2102 0
Australia
Phone 2102 0
+61 7 31386134
Fax 2102 0
Email 2102 0
r.zabel@qut.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.