ANZCTR - Registration

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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]

'Nil'

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Uraemia

Malnutrition

Chronic kidney disease

Condition category

Condition code

Renal and Urogenital

Kidney disease

Diet and Nutrition

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]

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]

Improved uraemic symptoms using PG-SGA, and a specific symptom questionaire designed for the study.

Timepoint [1]

Day 0,1,2,3,4,5,6,7, and 30

Secondary outcome [1]

Improved nutritional intake using 24 hour food recall

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Dialysis And Transplant Association

Address [1]

P.O. Box 165

Blackburn 3130

Victoria

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Austin Medical Research Foundation

Address [2]

Austin Health
145 Studley Rd
Heidelberg
Victoria 3084

Country [2]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Rd
Heidelberg
Vic 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Ethic Research Committee

Ethics committee address [1]

Austin Hospital
PO Box 5555
Heidelberg
Vic 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2012

Approval date [1]

25/01/2013

Ethics approval number [1]

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

Ms Karen Manley

Address

Austin Health
145 Studley Rd
Heidelberg
Vic 3084

Country

Australia

Phone

61 3 94965646

Fax

karen.manley@austin.org.au

Contact person for public queries

Name

Karen Manley

Address

Austin Health
145 Studley Rd
Heidelberg
Vic 3084

Country

Australia

Phone

+61 03 94965646

Fax

karen.manley@austin.org.au

Contact person for scientific queries

Name

Karen Manley

Address

Austin Health
145 Studley Rd
Heidelberg
Vic 3084

Country

Australia

Phone

+61 3 94965646

Fax

karen.manley@austin.org.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.

Trial Review

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