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Investigating two different refeeding formulations to improve safety and efficiency of hospital management of adolescent and young adults admitted with anorexia nervosa

Investigating two different refeeding formulations to improve safety and efficiency of hospital management of adolescent and young adults admitted with anorexia nervosa

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000342314
Enrollment
24
Registered
2017-03-06
Start date
2017-11-01
Completion date
2020-12-31
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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,

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.

Sponsors

Ms Elizabeth Parker
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

- Patients aged between 15 – 25 years - Current diagnosis of Anorexia Nervosa (DSM V criteria) - Requires nasogastric feeding for nutritional rehabilitation

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026