N/A
N=116
Study of Refeeding to Optimize iNpatient Gains
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT02488109 ↗Enrolled (actual)
116
Serious AEs
21.6%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Clinical Remission at Different Time Points of Assessment — 12; 8; 10; 13 Participants — p=0.42
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Higher Calorie Refeeding (Other); Lower Calorie Refeeding (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2020
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 |
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.
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
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.