Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000493549
Ethics application status
Approved
Date submitted
29/11/2006
Date registered
30/11/2006
Date last updated
31/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sturctured nutrition intervention in pre-dialysis chronic kidney disease
Scientific title
A randomized control trial to determine the effect of individualised nutrition counselling with structured follow-up on nutritional status, dietary intake and quality of life in pre-dialysis Stage IV chronic kidney disease patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV Chronic Kidney Disease 1471 0
Condition category
Condition code
Renal and Urogenital 1567 1567 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week prospective randomised-controlled trial.

The intervention treatment group are provided with an inital individual consultation with a dietitian at baseline, and are then followed up by telephone consultation, fortnightly for the first month, then monthly. The intervetion aims to nutrition prescription guidelines for energy (125-146kJ/kg/day), and protein (0.75 - 1.0g/kg/day) utilising self-management principles (goal setting, meal planning etc).

All participants are followed up at 12 weeks following baseline for a final nutrition assessment.
Intervention code [1] 1474 0
Lifestyle
Comparator / control treatment
The standard care participants receive a booklet containing a general overview of nutrition advice for chronic kidney disease and co-morbidity management.
Control group
Active

Outcomes
Primary outcome [1] 2162 0
Body cell mass (by measure of total body potassium)
Timepoint [1] 2162 0
At baseline and week 12
Secondary outcome [1] 3777 0
Dietary intake, subjective global assessment, quality of life and biochemistry.
Timepoint [1] 3777 0
Collected at baseline and week 12.

Eligibility
Key inclusion criteria
Adult chronic kidney disease patients with glomerular filtration rate 15 - 30ml/min, undergoing pre-dialysis treatment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous individualised dietetic intervention for Stage IV CKD; Patients with emotional, cognitive or language limitations impairing their ability to provide informed consent or comprehend dietary education, without a carer or interpreter available at home (determined from a nephrologists assessment); Patients who have established malnutrition, where the aetiology is other than renal disease, for example, cancer cachexia.

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)
Allocation involved contacting the holder of the allocation schedule who was off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1708 0
Charities/Societies/Foundations
Name [1] 1708 0
Royal Brisbane and Womens Hospital Foundation
Country [1] 1708 0
Australia
Funding source category [2] 1709 0
University
Name [2] 1709 0
Queensland University of Technology
Country [2] 1709 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 1508 0
Hospital
Name [1] 1508 0
Royal Brisbane and Womens Hospital
Address [1] 1508 0
Country [1] 1508 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3165 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 3165 0
Ethics committee country [1] 3165 0
Australia
Date submitted for ethics approval [1] 3165 0
Approval date [1] 3165 0
17/08/2004
Ethics approval number [1] 3165 0
2004/069
Ethics committee name [2] 3166 0
Queensland University of Technology
Ethics committee address [2] 3166 0
Ethics committee country [2] 3166 0
Australia
Date submitted for ethics approval [2] 3166 0
Approval date [2] 3166 0
19/07/2004
Ethics approval number [2] 3166 0
3547H

Summary
Brief summary
This study aims to determine the most effective nutrition management for patients with chronic kidney disease in terms of assessment and intervention methods.
It is expected that provision of individual nutrition counselling with structured telephone-based follow-up will improve the nutritional status, quality of life and dietary intake of chronic kidney disease patients preparing for dialysis compared with standard care treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27408 0
Address 27408 0
Country 27408 0
Phone 27408 0
Fax 27408 0
Email 27408 0
Contact person for public queries
Name 10663 0
Katrina Campbell
Address 10663 0
Institiute of Health and Biomedical Innovation (IHBI)
Cnr Blamey St and Musk Ave
Queensland University of Technology QLD
Country 10663 0
Australia
Phone 10663 0
(07) 3138 6090
Fax 10663 0
Email 10663 0
[email protected]
Contact person for scientific queries
Name 1591 0
Katrina Campbell
Address 1591 0
Institiute of Health and Biomedical Innovation (IHBI)
Cnr Blamey St and Musk Ave
Queensland University of Technology
Country 1591 0
Australia
Phone 1591 0
(07) 3138 6090
Fax 1591 0
Email 1591 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.