Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001351808
Ethics application status
Approved
Date submitted
21/07/2021
Date registered
7/10/2021
Date last updated
7/10/2021
Date data sharing statement initially provided
7/10/2021
Date results information initially provided
7/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Very Low Calorie Diet in Patients Receiving Haemodialysis
Scientific title
Safety and Efficacy of Very Low Calorie Diet (VLCD) in Patients Receiving Haemodialysis Therapy.
Secondary ID [1] 304837 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 322924 0
Haemodialysis 322925 0
Obesity 322926 0
Condition category
Condition code
Renal and Urogenital 320497 320497 0 0
Kidney disease
Diet and Nutrition 320498 320498 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietitian supervised very low calorie diet (VLCD) administered using meal replacement bars, shakes, soups and desserts (Optifast®, Nestle Health Science). Meal replacement products provided 600-800 calories per day. Patients will be provided with all meal replacements for the duration of the study. In addition to the meal replacement products patients were directed to consume 2 cups of low starch, low potassium vegetables plus 1 tsp oil per day. These were not supplied and patients were required to purchase these themselves.
Patients were assessed by renal dietitian weekly for the first four weeks and then fortnightly thereafter. One to one, face to face dietitian consultation and education including details regarding the individualised fluid restriction was performed. Dietitian consults were 30-60 minutes depending on number of questions and difficulties experienced by the patient. Duration of intervention 12 weeks. Adherence monitored via one to one interview and assessment of VLCD utilisation.
Intervention code [1] 321220 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328329 0
Change in Body Weight at 12 weeks (kg) using electronic scales
Timepoint [1] 328329 0
Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks (primary time-point)
Primary outcome [2] 328330 0
Incidence of hyperkalaemia (serum potassiumlevel >6.0 mmol/L) during 12 week intervention period. Potassium levels measured on blood samples obtained at each time point.
Timepoint [2] 328330 0
Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks (primary time-point)
Secondary outcome [1] 398621 0
Tolerability of the very low calorie diet assessed by patient interview by study dietician. The dietitian requested general feedback, as well as probing about changes to bowel habits/gastrointestinalI symptoms, flavour and fatigue.
No specific study questionnaire was used.
Timepoint [1] 398621 0
Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.

Eligibility
Key inclusion criteria
Adult patients >18 years on haemodialysis treatment either home or facility based.
Body mass index (BMI) greater than 30kg/m2 .
Able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking participants

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pragmatic pilot trial - no sample size calculation was performed. Departmental funding provided for sample size of between 20 to 25 participants. Linear mixed models will be used to compare primary and secondary outcomes over time in participants. An assessment of the effect by modality type will be tested by including an interaction between modality type and time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2017
Date of last participant enrolment
Anticipated
Actual
25/07/2018
Date of last data collection
Anticipated
Actual
2/12/2019
Sample size
Target
25
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20320 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 35062 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 309210 0
Hospital
Name [1] 309210 0
Department of Nephrology. Monash Medical Centre, Monash Health
Country [1] 309210 0
Australia
Primary sponsor type
Hospital
Name
Department of Nephrology. Monash Medical Centre, Monash Health
Address
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
Victoria 3168
Country
Australia
Secondary sponsor category [1] 310172 0
None
Name [1] 310172 0
Address [1] 310172 0
Country [1] 310172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309061 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 309061 0
Monash Medical Centre
246 Clayton Road
Clayton
Melbourne
Victoria 3168
Ethics committee country [1] 309061 0
Australia
Date submitted for ethics approval [1] 309061 0
Approval date [1] 309061 0
16/01/2017
Ethics approval number [1] 309061 0
HREC/16/MonH/427

Summary
Brief summary
The aim of this study is to determine if the use of a very low calorie diet (VLCD) with three meal replacement products per day is a safe and effective method for weight loss for patients with end stage renal failure undergoing haemodialysis (HD) therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112834 0
Prof Kevan Polkinghorne
Address 112834 0
Department of Nephrology
Monash Medical Centre
246 Clayton Road,
Clayton
Melbourne,
Victoria 3168
Country 112834 0
Australia
Phone 112834 0
+61 3 95943529
Fax 112834 0
Email 112834 0
[email protected]
Contact person for public queries
Name 112835 0
Ms Julie Woods
Address 112835 0
Department of Dietetics
Monash Medical Centre
246 Clayton Road,
Clayton
Melbourne,
Victoria 3168
Country 112835 0
Australia
Phone 112835 0
+61 3 95946666
Fax 112835 0
Email 112835 0
[email protected]
Contact person for scientific queries
Name 112836 0
Prof Kevan Polkinghorne
Address 112836 0
Department of Nephrology
Monash Medical Centre
246 Clayton Road,
Clayton
Melbourne,
Victoria 3168
Country 112836 0
Australia
Phone 112836 0
+61 3 95943529
Fax 112836 0
Email 112836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small Pilot Study


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.