Individualized Study of Refeeding to Optimize iNpatient Gains
NCT04966858 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2026-01-23
Summary
The primary purpose of the trial is to compare the efficacy and safety of Individualized Caloric Refeeding (ICR) to the new standard of care, Higher Calorie Refeeding (HCR), in hospitalized patients with atypical anorexia nervosa (AAN), and clinical remission over one year of follow-up.
Conditions
- Atypical Anorexia Nervosa
Interventions
- OTHER
-
Individualized Caloric Refeeding (ICR)
Meal-based refeeding in hospital, starting at 50 calories per kilogram of body weight, and increasing by 200 calories per day until caloric goal achieved
- OTHER
-
Higher Calorie Refeeding (HCR)
Meal-based refeeding in hospital, starting at 2000 calories per day, and increasing by 200 calories per day until caloric goal achieved
Sponsors & Collaborators
- collaborator OTHER
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Andrea K Garber, RD, PhD · University of California, San Francisco
-
Neville H Golden, MD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 24 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-12
- Primary Completion
- 2025-06-03
- Completion
- 2026-03-31
Countries
- United States
Study Locations
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