ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1192-8232

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anorexia nervosa

Malnutrition

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Mental Health

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]

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]

Hypophosphataemia

This will be assessed by monitoring blood samples that are taken as part of routine care.

Timepoint [1]

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]

Change in Weight

Timepoint [1]

During first 3 weeks of hospital admission.

Baseline, 1 week, 2 weeks and 3 weeks,.

Secondary outcome [2]

Number of hospital days.

Using medical records.

Timepoint [2]

Discharge from hospital

Secondary outcome [3]

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]

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]

Oedema

This will be assessed by a physical examination by the medical team. No tools required.

Timepoint [4]

Weekly medical assessment by treating team to assess for peripheral oedema during first 3 weeks of hospital admission.

Secondary outcome [5]

Serum Thiamine level

Timepoint [5]

Baseline and weekly thiamine measure during first 3 weeks of hospital admission

Secondary outcome [6]

Prescribed electrolyte replacement (phosphate, magnesium, potassium)

This will be assessed by checking the medical records.

Timepoint [6]

During first 3 weeks of hospital admission

Secondary outcome [7]

Admission to Intensive Care Unit (ICU).

This will be assessed using the medical records.

Timepoint [7]

During first 3 weeks of hospital admission

Secondary outcome [8]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment hospital [2]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Ministry of Health

Address [1]

73 Miller St, North Sydney NSW 2060

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Professor Victoria Flood

Address [1]

Faculty of Health Sciences
University of Sydney
75 East St
Lidcombe NSW 2141

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Fran Wilson

Address [2]

Department of Psychiatry
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Professor Michael Kohn

Address [3]

Department of Adolescent and Young Adult Medicine
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Professor Simon Clarke

Address [4]

Department of Adolescent and Young Adult Medicine
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Ms Elizabeth Frig

Address [5]

Department of Nutrition & Dietetics
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr Mark Halaki

Address [6]

Faculty of Health Sciences University of Sydney 75 East St Lidcombe NSW 2141

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District HREC

Ethics committee address [1]

Research Office, level 2, REN Building
Westmead Hospital
Cnr Hawkesbury & Darcy Roads
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/09/2016

Approval date [1]

31/10/2017

Ethics approval number [1]

Summary

Brief summary

Patients admitted to hospital with anorexia nervosa (AN) require nutritional rehabilitation to reverse malnutrition and its complications. However, conservative guidelines advocate reintroducing nutrition at a very slow rate to avoid refeeding complications. At the Children’s Hospital Westmead and the Adolescent ward of Westmead Hospital, adolescents with AN have been successfully treated with more aggressive nutrition intervention without adverse side effects, and with a more rapid improvement of weight status.

Evidence in higher caloric feeding is not as robust in the adult AN population as compared with adolescent patients. Of particular concern is the reintroduction of carbohydrate in a starved patient, which can lead to electrolyte derangement and increase the risk of developing refeeding complications. The standard enteral feed provided to patients provides 54% carbohydrate, while the literature suggests the use of continuous feeding strategies with less than 40% of energy from carbohydrate.

The aim of this study is to test if a lower carbohydrate (CHO) content enteral feed will provide better health outcomes to adolescent and young adult patients with AN. 

This study will be multi-centred, including Westmead Hospital and RPAH. Patients admitted with AN and requiring enteral tube feeding (TF) during an 18 month data collection period, will be randomly assigned to receive either: 
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;
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.

Expected total number of patients, n = 48, with 24 in each arm. Inclusion and exclusion criteria will apply to participants.
Primary outcome measure: Hypophosphataemia.
Secondary outcome measures: Change in weight, Length of hospital stay (LOS), hypoglycaemia (nocturnal and postprandial), oedema, thiamine, electrolyte replacement, admission to ICU, days required to reach medical stability.

This study has the potential to change practice in the nutritional management of young adults admitted with AN across the state, with the goal to inform future policy in this field. It will include the 2 hospitals in NSW with specialised inpatient treatment programs for adult patients with AN.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Elizabeth Parker

Address

Department of Dietetics
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 6638

Fax

+61 2 9845 8006

Elizabeth.Parker@health.nsw.gov.au

Contact person for public queries

Name

Elizabeth Parker

Address

Department of Dietetics
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 6638

Fax

+61 2 9845 8006

Elizabeth.Parker@health.nsw.gov.au

Contact person for scientific queries

Name

Michael Kohn

Address

Department of Adolescent and Young Adult Medicine
Westmead Hospital
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 6788

Fax

Michael.Kohn@health.nsw.gov.au

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 Elizabeth.Parker@health.nsw.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7245	Study protocol			Elizabeth.Parker@health.nsw.gov.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Study 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.	2020	https://dx.doi.org/10.1136/bmjopen-2020-038242

N.B. These documents automatically identified may not have been verified by the study sponsor.

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