Trial Review

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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
Scientific title
Can uraemic symptoms be reduced by changing the saliva environment in chronic kidney disease?
Secondary ID [1] 281455 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uraemia 287367 0
Malnutrition 287368 0
Chronic kidney disease 287487 0
Condition category
Condition code
Renal and Urogenital 287697 287697 0 0
Kidney disease
Diet and Nutrition 287818 287818 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285650 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 287945 0
Improved uraemic symptoms using PG-SGA, and a specific symptom questionaire designed for the study.
Timepoint [1] 287945 0
Day 0,1,2,3,4,5,6,7, and 30
Secondary outcome [1] 299102 0
Improved nutritional intake using 24 hour food recall
Timepoint [1] 299102 0
Day 1 and 30

Eligibility
Key inclusion criteria
chronic kidney disease patients with uraemic symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling or unable to sign consent form

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
3/06/2013
Date of last participant enrolment
Anticipated
29/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285968 0
Charities/Societies/Foundations
Name [1] 285968 0
Dialysis And Transplant Association
Country [1] 285968 0
Australia
Funding source category [2] 286225 0
Hospital
Name [2] 286225 0
Austin Medical Research Foundation
Country [2] 286225 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd
Heidelberg
Vic 3084
Country
Australia
Secondary sponsor category [1] 284792 0
None
Name [1] 284792 0
Address [1] 284792 0
Country [1] 284792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288000 0
Austin Health Human Ethic Research Committee
Ethics committee address [1] 288000 0
Austin Hospital
PO Box 5555
Heidelberg
Vic 3084
Ethics committee country [1] 288000 0
Australia
Date submitted for ethics approval [1] 288000 0
01/12/2012
Approval date [1] 288000 0
25/01/2013
Ethics approval number [1] 288000 0

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.
Trial website
Trial related presentations / publications
Manley KJ, (2015) Taste genetics and gastrointestinal symptoms in chronic kidney disease. Euro J Clin Nut.;69:781-785
Public notes

Contacts
Principal investigator
Name 34687 0
Ms Karen Manley
Address 34687 0
Austin Health
145 Studley Rd
Heidelberg
Vic 3084
Country 34687 0
Australia
Phone 34687 0
61 3 94965646
Fax 34687 0
Email 34687 0
[email protected]
Contact person for public queries
Name 17934 0
Karen Manley
Address 17934 0
Austin Health
145 Studley Rd
Heidelberg
Vic 3084
Country 17934 0
Australia
Phone 17934 0
+61 03 94965646
Fax 17934 0
Email 17934 0
[email protected]
Contact person for scientific queries
Name 8862 0
Karen Manley
Address 8862 0
Austin Health
145 Studley Rd
Heidelberg
Vic 3084
Country 8862 0
Australia
Phone 8862 0
+61 3 94965646
Fax 8862 0
Email 8862 0
[email protected]

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.