Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000110886
Ethics application status
Approved
Date submitted
19/01/2012
Date registered
24/01/2012
Date last updated
24/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of oral supplementation on nutritional status, appetite and quality of life of peritoneal dialysis patients.
Scientific title
In peritoneal dialysis patients does oral nutritional supplementation, compared with the pre-supplementation period, improve nutritional status?
Secondary ID [1] 279759 0
Nil
Universal Trial Number (UTN)
U1111-1127-3585
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Dialysis Patients 285625 0
Condition category
Condition code
Renal and Urogenital 285817 285817 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: oral nutritional supplement in a liquid form (i.e. a drink) providing 19g protein and 1.1 kJ of energy.
Arm 2: oral nutritional supplement in a solid form (i.e. a snack bar) providing 19g protein and 1.1 kJ of energy.

Each supplement will be consumed once per day (i.e one drink or one bar) for 8 weeks.
Intervention code [1] 284077 0
Treatment: Other
Comparator / control treatment
There is no control group. This is a within subject cross-over trial and results will be compared to the pre-supplementation period (i.e looking at a change from baseline). Each participant will move from arm 1 to arm 2, and vice versa, thus having both forms of the supplement. There will be no washout between the cross over. This is because the aims of the project are to assess nutritional supplementation for 16 weeks (independent of supplement type) and to also assess participant preference for each supplement type, which does not require a washout period.
Control group
Active

Outcomes
Primary outcome [1] 286329 0
Participant weight in kilogram
Timepoint [1] 286329 0
Baseline, week 8 and week 16
Primary outcome [2] 286330 0
Nutritional status will be measured using the Patient Generated Subjective Global Assessment (PG-SGA) tool. This tool widely used in standard dietetic practice and has been shown to have favorable clinometric properties when used in the renal population.
Timepoint [2] 286330 0
Baseline, week 16
Primary outcome [3] 286331 0
Nutritional biochemical indices: serum albumin, transthyretin, urea and CRP will be recorded.
Timepoint [3] 286331 0
Baseline, week 8 and week 16
Secondary outcome [1] 295614 0
Participant preference of supplement type.

Acceptance of the supplement will be measured using an unstructured line scale. The unstructured line scale is 100 mm in length, and is anchored with 'dislike extremely' and 'like extremely' on opposing ends of the scale.

At the completion of the study participants will be asked to choose their preferred supplement (drink or snack bar) using a questionnaire that includes an option to select a tied category.
Timepoint [1] 295614 0
Baseline, week 8 and week 16
Secondary outcome [2] 295615 0
Health-related quality of life. Two quality of life indices will be used, a disease specific (KDHRQOL) and a generic instrument (EQ-5D)
Timepoint [2] 295615 0
Baseline and week 16
Secondary outcome [3] 295616 0
Appetite using visual analog scales
Timepoint [3] 295616 0
Baseline, week 8 and week 16

Eligibility
Key inclusion criteria
Peritoneal Dialysis patients who are malnourished or at risk of or malnourishment according to PG-SGA or who have serum albumin less than 35g/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age

Patients on peritoneal dialysis for less than 3 months

Patients with physical, cognitive, language or emotional problems which would prevent participation

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 eligible peritoneal patients will be invited to participate in the trial. Those consenting will be randomized to receive the liquid supplement followed by the solid supplement or the solid supplement followed by the liquid supplement. Allocation concealment will occur by using opaque, consecutively numbered, sealed envelopes with the group allocation written on a piece of paper inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be constructed using simple randomization determined using a computer program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284545 0
Charities/Societies/Foundations
Name [1] 284545 0
Australian and New Zealand Society of Nephrology
Country [1] 284545 0
Australia
Primary sponsor type
Hospital
Name
Southern Health - Monash Medical Centre
Address
Department of Dietetics
Monash Medical Centre
246 Clayton Rd
Clayton 3168
VIC
Country
Australia
Secondary sponsor category [1] 283471 0
None
Name [1] 283471 0
Address [1] 283471 0
Country [1] 283471 0
Other collaborator category [1] 260464 0
University
Name [1] 260464 0
Monash University
Address [1] 260464 0
Wellington Road
Clayton 3800
VIC
Country [1] 260464 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286530 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 286530 0
Research Directorate
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Australia
Ethics committee country [1] 286530 0
Australia
Date submitted for ethics approval [1] 286530 0
Approval date [1] 286530 0
15/12/2011
Ethics approval number [1] 286530 0
11392B

Summary
Brief summary
Malnutrition is a significant and highly prevalent problem in those undergoing peritoneal dialysis (PD), and has been associated with increased morbidity and mortality. PD patients often experience gastrointestinal symptoms and together with a fluid restricted diet can limit the tolerance to nutritional supplements. The goal of this study is to evaluate the efficacy of provision of a nutritional supplement, given as a liquid (drink) or a food (snack bar) for improving the health outcomes of PD patients who are malnourished.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33656 0
Address 33656 0
Country 33656 0
Phone 33656 0
Fax 33656 0
Email 33656 0
Contact person for public queries
Name 16903 0
Karen Salamon
Address 16903 0
Dietetics Department
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 16903 0
Australia
Phone 16903 0
+61 3 9594 4068
Fax 16903 0
Email 16903 0
Karen.Salamon@southernhealth.org.au
Contact person for scientific queries
Name 7831 0
Karen Salamon
Address 7831 0
Dietetics Department
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 7831 0
Australia
Phone 7831 0
+61 3 9594 4068
Fax 7831 0
Email 7831 0

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.