Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000681853
Ethics application status
Approved
Date submitted
8/04/2021
Date registered
3/06/2021
Date last updated
12/04/2023
Date data sharing statement initially provided
3/06/2021
Date results provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
To validate a phosphate food frequency questionnaire using dietary recalls and test for reproducibility in people with end stage kidney failure on dialysis.
Scientific title
Validation of a dIalysis Phosphate FFQ in kidney failure patients – VIP - kidney
Secondary ID [1] 303917 0
Nil Known.
Universal Trial Number (UTN)
Trial acronym
ViP - Kidney
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 321501 0
Hyperphosphatemia 321502 0
Condition category
Condition code
Renal and Urogenital 319251 319251 0 0
Kidney disease
Diet and Nutrition 319570 319570 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In an initial dietetic consultation participants will complete the phosphate specific FFQ survey (this consists of 31 foods that are high sources of dietary phosphorous ranked in order of frequency from never to 2 or more times per day) and a 24 hour multi pass recall which will be verified by the renal dietitian in an interview-administered methodology. This will confirm the reported number of serves, portion sizes and take-aways as well as brand names of regular packaged foods in the survey. Participants will also via interview with the dietitian complete a further two 24-hour multi pass recalls so that there is one that covers a dialysis day, a non-dialysis weekday and a non-dialysis weekend day. Where possible participants will be encouraged to take photographs of packaged meals to confirm exact brand and type. All information will be collected on paper, scanned in by the renal dietitian and sent to the principal investigator for data entry and analysis. In total the patient will have 3 interviews ( 1 x 60 mins and 2 x 30 mins) with the dietitian (via Telehealth or face to face if patient prefers) over a period of 2 weeks.

The same participants will be invited to opt-in to a sub-study to also provide weighted 24-hour food records, reflecting a dialysis and non-dialysis day in the following week. Those that opt in for the sub study will be given verbal and written instructions on how to accurately measure foods and how to complete the food record and will be provided with scales, measuring cups, spoons, and food recording sheets. The patient will have 1 extra interview lasting 30 minutes with the patient to explain the procedure. The sub study will begin 1 week after the patient has completed the interviews for the main observational study.
Intervention code [1] 320219 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327131 0
To confirm that the phosphate specific FFQ is an accurate indicator of dietary intake by comparing it with a validated 24 hr multi pass recall tool.
This will be assessed using the nutrient analysis program FoodWorks v.10 (Xyris Software Australia Pty Ltd).
Timepoint [1] 327131 0
3 weeks post baseline interview.
Secondary outcome [1] 393907 0
Dietary patterns (frequency) on dialysis and non-dialysis days recorded from 24 hr multi pass recall and analysed on FoodWorks software program.
Timepoint [1] 393907 0
4 weeks post baseline interview.
Secondary outcome [2] 395111 0
Percentage of dietary phosphate intake from animal, vegetable, and food additive sources. This will be assessed using analysis of the FFQ and 24hr multi pass recall from the nutrient analysis program FoodWorks V.10
Timepoint [2] 395111 0
4 weeks post baseline interview.

Eligibility
Key inclusion criteria
• On dialysis (peritoneal dialysis or haemodialysis (home or facility-based)) for at least 3 months who are able to provide informed consent
• Age >= 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Hospitalisation within the last 1 month
• Serious intercurrent illness within the last 1 month
• Unable to complete the FFQ e.g. patients with dementia, cognitive deficit and/or language barrier

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Bland - Altman analyses will be used to determine agreement between FFQ and 24 hr recall methods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2021
Actual
9/07/2021
Date of last participant enrolment
Anticipated
1/10/2022
Actual
1/08/2022
Date of last data collection
Anticipated
1/11/2022
Actual
1/08/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19076 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 19077 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 19078 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 33631 0
6009 - Nedlands
Recruitment postcode(s) [2] 33632 0
6230 - Bunbury
Recruitment postcode(s) [3] 33633 0
6000 - Perth
Recruitment postcode(s) [4] 33634 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 308304 0
Hospital
Name [1] 308304 0
Sir Charles Gairdner Hospital
Country [1] 308304 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 309108 0
None
Name [1] 309108 0
Address [1] 309108 0
Country [1] 309108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308280 0
Sir Charles Gairdner Osborne Park Health Care Group Ethics Commitee
Ethics committee address [1] 308280 0
Ethics committee country [1] 308280 0
Australia
Date submitted for ethics approval [1] 308280 0
01/04/2021
Approval date [1] 308280 0
10/06/2021
Ethics approval number [1] 308280 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110162 0
Mrs Joanne Beer
Address 110162 0
Nutrition and Dietetics Department
Osborne Park Hospital
Osborne Place, Stirling,
WA 6021
Country 110162 0
Australia
Phone 110162 0
+61 403938747
Fax 110162 0
Email 110162 0
[email protected]
Contact person for public queries
Name 110163 0
Joanne Beer
Address 110163 0
Nutrition and Dietetics Department
Osborne Park Hospital
Osborne Place, Stirling,
WA 6021
Country 110163 0
Australia
Phone 110163 0
+61 403938747
Fax 110163 0
Email 110163 0
[email protected]
Contact person for scientific queries
Name 110164 0
Joanne Beer
Address 110164 0
Nutrition and Dietetics Department
Osborne Park Hospital
Osborne Place, Stirling,
WA 6021
Country 110164 0
Australia
Phone 110164 0
+61 403938747
Fax 110164 0
Email 110164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant dietary data after de-identification.
When will data be available (start and end dates)?
Following publication and available for 5 years after publication.
Available to whom?
Researchers and case by case.
Available for what types of analyses?
Validation of FFQ tool
How or where can data be obtained?
Via principle investigator Joanne Beer
[email protected]


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.