Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000342314
Ethics application status
Approved
Date submitted
10/02/2017
Date registered
6/03/2017
Date last updated
5/03/2020
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating two different refeeding formulations to improve safety and efficiency of hospital management of adolescent and young adults admitted with anorexia nervosa
Scientific title
Investigating two different refeeding formulations to improve safety and efficiency of hospital management of adolescent and young adults admitted with anorexia nervosa
Secondary ID [1] 291156 0
None
Universal Trial Number (UTN)
U1111-1192-8232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 302015 0
Malnutrition 302017 0
Condition category
Condition code
Diet and Nutrition 301656 301656 0 0
Other diet and nutrition disorders
Mental Health 301709 301709 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be multi-centred, including Westmead Hospital and RPAH. Patients admitted with Anorexia Nervosa and requiring enteral tube feeding (TF) during an 18 month data collection period, will be randomly assigned to receive either Arm 1 (standard feeding formula) or Arm 2 (trial treatment formula).

Arm 2. Trial treatment regime of nasogastric feeding commencing at 35mL/hr for 12 hours, providing 630kcal, 26g protein, 45g carbohydrate, 39g fat in 420mL feed, using a lower carbohydrate, higher fat formula (Pulmocare 28% CHO, 56% fat), and progressing to a rate up to 70mL/hr as tolerated.


Duration of treatment will be up to the first 3 weeks of hospital admission when requiring tube feeding. For most patients, they will require treatment from day of admission, however some patients may require the treatment after a few days (after it has been established that they require nasogastric tube feeding).

Monitoring of compliance is part of routine care, e.g. feeding rate regularly checked by nursing staff and recorded on fluid balance charts, Routine care of eating disorder patients also includes taping the connection between the bottle of feed and connecting tube, to prevent tampering with feeds.
Intervention code [1] 297145 0
Treatment: Other
Comparator / control treatment
Arm 1:. Standard treatment regime of nasogastric feeding (using an enteral feed with a carbohydrate content similar to standard care) commencing at 35mL/hr for 12 hours, providing 630kcal, 26g protein, 86g carbohydrate, 21g fat in 420mL feed, using a standard polymeric formula (Ensure Plus 54% CHO, 26% fat), and progressing to a rate up to 70mL/hr as tolerated;
Control group
Active

Outcomes
Primary outcome [1] 301049 0
Hypophosphataemia

This will be assessed by monitoring blood samples that are taken as part of routine care.
Timepoint [1] 301049 0
During first 3 weeks of hospital admission.

Baseline, 6-8 hours after starting feeds, then daily for the first week, 2nd daily during the second week, then at the end of week 3.
Secondary outcome [1] 331579 0
Change in Weight
Timepoint [1] 331579 0
During first 3 weeks of hospital admission.

Baseline, 1 week, 2 weeks and 3 weeks,.
Secondary outcome [2] 331580 0
Number of hospital days.

Using medical records.
Timepoint [2] 331580 0
Discharge from hospital
Secondary outcome [3] 331590 0
Hypoglycaemia

Monitoring of Blood Glucose Level (BGL) is part of routine care. Will monitor blood tests at baseline, and 60-90 minutes after breakfast for first 1 week of admission using glucometer. This will cease after one week if BGL normal.
Timepoint [3] 331590 0
Postprandial 60-90 minutes after breakfast daily during first 1 week of hospital admission. This will cease after one week if BGL normal.
Secondary outcome [4] 331591 0
Oedema

This will be assessed by a physical examination by the medical team. No tools required.
Timepoint [4] 331591 0
Weekly medical assessment by treating team to assess for peripheral oedema during first 3 weeks of hospital admission.
Secondary outcome [5] 331593 0
Serum Thiamine level
Timepoint [5] 331593 0
Baseline and weekly thiamine measure during first 3 weeks of hospital admission
Secondary outcome [6] 331594 0
Prescribed electrolyte replacement (phosphate, magnesium, potassium)

This will be assessed by checking the medical records.
Timepoint [6] 331594 0
During first 3 weeks of hospital admission
Secondary outcome [7] 331595 0
Admission to Intensive Care Unit (ICU).

This will be assessed using the medical records.
Timepoint [7] 331595 0
During first 3 weeks of hospital admission
Secondary outcome [8] 331596 0
Number of days to reach medical stability (e.g. Heart rate > 50 beats per minute)

This will be assessed by using the medical records.
Timepoint [8] 331596 0
During first 3 weeks of hospital admission

Eligibility
Key inclusion criteria
- Patients aged between 15 – 25 years
- Current diagnosis of Anorexia Nervosa (DSM V criteria)
- Requires nasogastric feeding for nutritional rehabilitation
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients aged less than 15 years old or greater than 25 year old
- Patients admitted with eating disorders other than AN (e.g. Bulimia nervosa)
- Patients not requiring nasogastric feeding as part of nutritional rehabilitation

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation was calculated using a dichotomous endpoint two independent study sample, incidence of 45% hypophosphatemia in the standard feed arm and 10% hypophosphatemia in the treatment feed arm, 48 patients (24 in each arm) would have 80% power, alpha 0.05.

Data will be analysed using IBM Statistical Package for Social Sciences (SPSS), version 21 IBM Corporation. Continuous outcomes will be assessed for normality and if normally distributed the two treatment groups will be compared using independent t-tests. Binary outcomes will be compared using a chi-squared test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2017
Actual
1/11/2017
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
21/01/2021
Actual
Sample size
Target
48
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7464 0
Westmead Hospital - Westmead
Recruitment hospital [2] 7465 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 15291 0
2145 - Westmead
Recruitment postcode(s) [2] 15292 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 295592 0
Government body
Name [1] 295592 0
NSW Ministry of Health
Country [1] 295592 0
Australia
Primary sponsor type
Individual
Name
Ms Elizabeth Parker
Address
Department of Dietetics & Nutrition
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 294426 0
None
Name [1] 294426 0
Address [1] 294426 0
Country [1] 294426 0
Other collaborator category [1] 279423 0
Individual
Name [1] 279423 0
Professor Victoria Flood
Address [1] 279423 0
Faculty of Health Sciences
University of Sydney
75 East St
Lidcombe NSW 2141
Country [1] 279423 0
Australia
Other collaborator category [2] 279424 0
Individual
Name [2] 279424 0
Dr Fran Wilson
Address [2] 279424 0
Department of Psychiatry
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country [2] 279424 0
Australia
Other collaborator category [3] 279425 0
Individual
Name [3] 279425 0
Professor Michael Kohn
Address [3] 279425 0
Department of Adolescent and Young Adult Medicine
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country [3] 279425 0
Australia
Other collaborator category [4] 279426 0
Individual
Name [4] 279426 0
Professor Simon Clarke
Address [4] 279426 0
Department of Adolescent and Young Adult Medicine
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country [4] 279426 0
Australia
Other collaborator category [5] 279427 0
Individual
Name [5] 279427 0
Ms Elizabeth Frig
Address [5] 279427 0
Department of Nutrition & Dietetics
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country [5] 279427 0
Australia
Other collaborator category [6] 279958 0
Individual
Name [6] 279958 0
Dr Mark Halaki
Address [6] 279958 0
Faculty of Health Sciences University of Sydney 75 East St Lidcombe NSW 2141
Country [6] 279958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296915 0
Western Sydney Local Health District HREC
Ethics committee address [1] 296915 0
Ethics committee country [1] 296915 0
Australia
Date submitted for ethics approval [1] 296915 0
21/09/2016
Approval date [1] 296915 0
31/10/2017
Ethics approval number [1] 296915 0

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

Contacts
Principal investigator
Name 72418 0
Ms Elizabeth Parker
Address 72418 0
Department of Dietetics
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country 72418 0
Australia
Phone 72418 0
+61 2 9845 6638
Fax 72418 0
+61 2 9845 8006
Email 72418 0
[email protected]
Contact person for public queries
Name 72419 0
Elizabeth Parker
Address 72419 0
Department of Dietetics
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country 72419 0
Australia
Phone 72419 0
+61 2 9845 6638
Fax 72419 0
+61 2 9845 8006
Email 72419 0
[email protected]
Contact person for scientific queries
Name 72420 0
Michael Kohn
Address 72420 0
Department of Adolescent and Young Adult Medicine
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country 72420 0
Australia
Phone 72420 0
+61 2 9845 6788
Fax 72420 0
Email 72420 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?
Deidentified data collection on intervention and outcome measures
When will data be available (start and end dates)?
Data will be made available for 7 years after completion of thesis and publication.
Available to whom?
Clinical researchers who contact the research team and discuss their proposed research.
Available for what types of analyses?
Outcome measure analysis. To be discussed with the research team.
How or where can data be obtained?
By emailing the principal investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7245Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa.2020https://dx.doi.org/10.1136/bmjopen-2020-038242
N.B. These documents automatically identified may not have been verified by the study sponsor.