Individualized Study of Refeeding to Optimize iNpatient Gains

NCT04966858 | Enrolling By Invitation DMC

• 5 other identifiers: 2R01HD082166-06A120-32551R01HD082166HD082166P0547076
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Malnutrition; Refeeding; Nutritional Rehabilitation; Adolescent Medicine

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Medical Stability in Hospital

  Medical stability will be adjudicated by a five-point index: (1) 24 hour heart rate of 45 beats/min or more, (2) systolic blood pressure of 90 millimeters of mercury (mmHg) or more, (3) temperature of 35.6° C or more, (4) orthostatic increase in heart rate of 35 beats/min or less, (5) orthostatic change in systolic blood pressure of 20 mmHg or less.

  Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks

Secondary Outcomes (1)

• Incidence of low serum electrolytes during refeeding in hospital

  Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks

Other Outcomes (2)

• Percentage median BMI (mBMI) Over 12 Months

  12 months post-study hospitalization

• Eating Disorder Examination Questionnaire (EDE-Q) Score Over 12 Months

  12 months post-study hospitalization

Study Arms (2)

Individualized Caloric Refeeding (ICR)

EXPERIMENTAL

Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal

Other: Individualized Caloric Refeeding (ICR)

Higher Calorie Refeeding (HCR)

ACTIVE COMPARATOR

Starting 2000 kcal/d, increasing by 200 kcal/d to goal

Other: Higher Calorie Refeeding (HCR)

Interventions

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

Also known as: HCR

Higher Calorie Refeeding (HCR)

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

Also known as: ICR

Individualized Caloric Refeeding (ICR)

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-24 yrs
• Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN
• Hospitalized with medical instability, as defined by:
• night time heart rate (HR) \<45 bpm,
• systolic blood pressure (SBP) \<90 mmHg,
• temperature \<35.6° C,
• orthostatic Δ HR \>35 bpm, or
• orthostatic Δ SBP \>20 mmHg

You may not qualify if:

• Bulimia nervosa
• Current pregnancy
• Chronic disease (e.g. immune, renal disease)
• Acute/active suicidality or psychosis
• Hospital admissions for refeeding in the prior 6 mo.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Stanford University Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

University of California, San Francisco Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Andrea K Garber, RD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Neville H Golden, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatments are not to be blinded, since both the patients and clinicians who work with this population are highly skilled at estimating kcal and would be able to determine group assignment by simply viewing meal trays.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be recruited upon hospital admission at the University of California, San Francisco (UCSF) and Stanford and randomly assigned to Individualized Caloric Refeeding (ICR) or Higher Calorie Refeeding (HCR) for the duration of the hospitalization. Treatment ends at hospital discharge with open follow-up for one year. Participants followed daily in hospital and at 3mo, 6mo, 9mo, and 12mo post-discharge.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: October 12, 2021
• Primary Completion: June 3, 2025
• Study Completion: March 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)