Individualized Study of Refeeding to Optimize iNpatient Gains

Part of paid clinical trials in Palo Alto, California.

Sponsor
University of California, San Francisco
Study ID
NCT04966858
Status
Enrolling By Invitation

Conditions

  • Atypical Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
12 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Individualized Caloric Refeeding (ICR) — OTHER
    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
  • Higher Calorie Refeeding (HCR) — OTHER
    Meal-based refeeding in hospital, starting at 2000 calories per day, and increasing by 200 calories per day until caloric goal achieved

Study Details

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.

Key Dates

Start date
Oct 12, 2021
Status verified
Jan 2026
Primary completion
Jun 3, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Individualized Caloric Refeeding (ICR)
    Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal
  • Active Comparator: Higher Calorie Refeeding (HCR)
    Starting 2000 kcal/d, increasing by 200 kcal/d to goal

Primary Outcome Measure

Time to Achieve Medical Stability in Hospital [ Time Frame: Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford University Lucille Packard Children's HospitalPalo AltoCalifornia94304-
University of California, San Francisco Benioff Children's HospitalSan FranciscoCalifornia94158-

Find similar trials in Palo Alto, CA

By research site
Stanford University Lucille Packard Children's Hospital· Palo Alto, CAUniversity of California, San Francisco Benioff Children's Hospital· San Francisco, CA

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