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Trial registered on ANZCTR
Registration number
ACTRN12612001144808
Ethics application status
Approved
Date submitted
21/09/2012
Date registered
30/10/2012
Date last updated
4/09/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Can uraemic symptoms be reduced by changing the saliva environment in chronic kidney disease
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Scientific title
Can uraemic symptoms be reduced by changing the saliva environment in chronic kidney disease?
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Secondary ID [1]
281455
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'Nil'
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uraemia
287367
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Malnutrition
287368
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Chronic kidney disease
287487
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Condition category
Condition code
Renal and Urogenital
287697
287697
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0
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Kidney disease
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Diet and Nutrition
287818
287818
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Trial mouthrinses of various solutions of common oral fluids to see what impoves taste and symptoms of uraemia
Salt 5g dissolved in 500ml cold water
Sodium bicarbonate 5g dissolved in 500ml cold water
Citric acid 1g dissolved in 500mlcold water
500ml de-ionised water
Sip and spit as required
Random sequence 1 each day.
Questionaire re tolerance and symptom.
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Intervention code [1]
285650
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Treatment: Other
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Comparator / control treatment
4 solutions were trialled
Salt 5g dissolved in 500ml cold water
Sodium bicarbonate 5g dissolved in 500ml cold water
Citric acid 1g dissolved in 500mlcold water
500ml de-ionised water
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Control group
Active
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Outcomes
Primary outcome [1]
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Improved uraemic symptoms using PG-SGA, and a specific symptom questionaire designed for the study.
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Assessment method [1]
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Timepoint [1]
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Day 0,1,2,3,4,5,6,7, and 30
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Secondary outcome [1]
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Improved nutritional intake using 24 hour food recall
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Assessment method [1]
299102
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Timepoint [1]
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Day 1 and 30
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Eligibility
Key inclusion criteria
chronic kidney disease patients with uraemic symptoms
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unwilling or unable to sign consent form
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All renal patients screened by PG-SGA with gastric uraemic symptoms will be asked to participate. Allocation not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Crossover. All the participatants receive all the interventions in different sequences during the study acting as their own control. On selection of the solution that improves that patient's symptoms the most, the solution code will be revealed and the patient will continue using this solution as needed from day eight to day 30.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2013
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Actual
3/06/2013
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Date of last participant enrolment
Anticipated
29/04/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
42
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
285968
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Charities/Societies/Foundations
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Name [1]
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Dialysis And Transplant Association
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Address [1]
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P.O. Box 165
Blackburn 3130
Victoria
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Country [1]
285968
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Australia
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Funding source category [2]
286225
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Hospital
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Name [2]
286225
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Austin Medical Research Foundation
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Address [2]
286225
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Austin Health
145 Studley Rd
Heidelberg
Victoria 3084
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Country [2]
286225
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
145 Studley Rd
Heidelberg
Vic 3084
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Country
Australia
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Secondary sponsor category [1]
284792
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None
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Name [1]
284792
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Address [1]
284792
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Country [1]
284792
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288000
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Austin Health Human Ethic Research Committee
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Ethics committee address [1]
288000
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Austin Hospital
PO Box 5555
Heidelberg
Vic 3084
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Ethics committee country [1]
288000
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Australia
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Date submitted for ethics approval [1]
288000
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01/12/2012
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Approval date [1]
288000
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25/01/2013
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Ethics approval number [1]
288000
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Summary
Brief summary
Patients with renal failure feel increasingly unwell as the disease progresses. The onset of taste changes, nausea, vomiting, fatigue, anorexia, and weight loss is thought to be due to an accumulation of toxins that the kidney can no longer get rid of as the patient becomes more and more uraemic. No single uraemic toxin has been identified that accounts for all the clinical symptoms. Taste influences food palatability and appetite and may cause an inadequate dietary intake contributing to malnutrition often seen in renal failure. Patients with kidney disease often suffer taste and upper gastro-intestinal problems and may need to start dialysis due to these symptoms. This implicates an accumulation of toxins but the responsible toxins have not been determined.
The purpose of this project is to improve health outcomes and nutritional management of patients with chronic kidney disease. We would like to find out which strategies improve uraemic symptoms such as taste changes and nausea often experienced by chronic renal failure patients. If the reasons for these symptoms are found, the most suitable techniques to improve their symptoms can be determined. This would enhance renal patients’ wellbeing and potentially their nutritional status and may delay the need for dialysis.
A total of 30 people will be asked to participate in this project recruited from the Renal outpatient clinics. Patients will be asked to provide saliva sample for analysis on two separate occasions. They will be asked to complete a questionnaire on symptoms concerned with taste and eating and record what they eat over 24hours at the start of the study and at the end of the study. Patients will be asked to taste and rate a variety of fluids using common foods or food ingredients thought to influence uraemic symptoms. Patients will then be asked to sip or rinse their mouth with the fluid they felt most beneficial to their symptoms for about 3 weeks. The toxins found in the saliva will be compared to symptoms and the solutions chosen and if their use improved any uraemic symptoms and nutritional intake.
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Trial website
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Trial related presentations / publications
Manley KJ, (2015) Taste genetics and gastrointestinal symptoms in chronic kidney disease. Euro J Clin Nut.;69:781-785
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Public notes
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Contacts
Principal investigator
Name
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Ms Karen Manley
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Address
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Austin Health
145 Studley Rd
Heidelberg
Vic 3084
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Country
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Australia
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Phone
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61 3 94965646
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Karen Manley
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Address
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Austin Health
145 Studley Rd
Heidelberg
Vic 3084
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Country
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Australia
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Phone
17934
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+61 03 94965646
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Karen Manley
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Address
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Austin Health
145 Studley Rd
Heidelberg
Vic 3084
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Country
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Australia
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Phone
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+61 3 94965646
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Fax
8862
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Email
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[email protected]
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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.
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