Individualized Study of Refeeding to Optimize iNpatient Gains

NCT ID: NCT04966858

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2026-03-31

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.

Detailed Description

Atypical Anorexia Nervosa (AAN) is a new diagnosis describing patients with malnutrition and significant weight loss yet "normal" weight. These patients responded poorly to HCR, the superior refeeding treatment in the parent trial, which was designed for low-weight patients with typical AN. The proposed trial will examine the safety and efficacy of a new treatment for AAN with the potential to improve treatment outcomes for this diverse and growing patient population. The major finding motivating the proposed trial is that participants with AAN gained weight 40 percent slower and required 3.0 additional days in hospital to restore medical stability on HCR, as compared to AN. The research team has developed Individualized Caloric Refeeding (ICR), which doses calories to weight consistent with other pediatric treatments (e.g. medication).

The primary purpose of the proposed trial is to compare the efficacy and safety of ICR to the new standard of care (HCR) in hospitalized patients with AAN. The investigators hypothesize that ICR will restore medical stability faster than HCR with no increase in electrolyte abnormalities. After hospitalization, the major barrier to care in AAN is lack of consensus on clinical remission and whether these formerly overweight patients should gain weight to recover. The research team will examine metabolic, hormonal and psychological markers during long-term follow-up, toward the goal of developing a definition of clinical remission in AAN.

Design Summary: Randomized controlled trial in N=74 participants age 12-24 with AAN, consented upon hospital admission, randomly assigned to ICR or HCR, followed daily in hospital and at 3, 6, 9 and 12 mo.

Conditions

Atypical Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individualized Caloric Refeeding (ICR)

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

Group Type: EXPERIMENTAL

Individualized Caloric Refeeding (ICR)

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Higher Calorie Refeeding (HCR)

Intervention Type: OTHER

Meal-based refeeding in hospital, starting at 2000 calories per day, and increasing by 200 calories per day until caloric goal achieved

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

ICR; HCR

Eligibility Criteria

Inclusion Criteria

• Age 12-24 yrs
• Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN
• Hospitalized with medical instability, as defined by:

1. night time heart rate (HR) <45 bpm,

2. systolic blood pressure (SBP) <90 mmHg,

3. temperature <35.6° C,

4. orthostatic Δ HR >35 bpm, or

5. orthostatic Δ SBP >20 mmHg

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea K Garber, RD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Neville H Golden, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Lucille Packard Children's Hospital

Palo Alto, California, United States

University of California, San Francisco Benioff Children's Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

20-32551

Identifier Type: OTHER

Identifier Source: secondary_id

R01HD082166

Identifier Type: NIH

Identifier Source: secondary_id

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HD082166

Identifier Type: OTHER

Identifier Source: secondary_id

P0547076

Identifier Type: OTHER

Identifier Source: secondary_id

2R01HD082166-06A1

Identifier Type: NIH

Identifier Source: org_study_id

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