N/A Completed N=116 Randomized Treatment

Study of Refeeding to Optimize iNpatient Gains

Anorexia nervosa

Source: ClinicalTrials.gov NCT02488109 ↗

Enrolled (actual)

116

Serious AEs

21.6%

Results posted

Jun 2021

Primary outcomePrimary: Number of Participants With Clinical Remission at Different Time Points of Assessment — 12; 8; 10; 13 Participants — p=0.42

Summary

The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia nervosa.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Remission at Different Time Points of Assessment	12; 8; 10; 13; 16; 10	0.42
SECONDARY Time to Achieve Medical Stability in Hospital	7.0; 10.0	0.01 sig

Eligibility Criteria

Inclusion Criteria

diagnosis of AN
atypical AN
no hospital admissions for the previous six months
meet hospitalization criteria: daytime heart rate (HR) 35 bpm or decrease in systolic BP > 20 mmHg or decrease in diastolic BP > 10 mmHg from lying to standing

Exclusion Criteria

diagnosis of bulimia nervosa [DSM-5]
currently in remission (as defined by weight and EDE-Q score)
admission for food refusal without malnutrition
current pregnancy
chronic disease (e.g. immune/endocrine disorders, pulmonary, cardiac, or renal disease)
current suicidality or psychosis
< 60% mBMI

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02488109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.