Individualized Study of Refeeding to Optimize iNpatient Gains

Not Applicable

• Conditions: Atypical Anorexia Nervosa
• Interventions: Other: Individualized Caloric Refeeding (ICR); Other: Higher Calorie Refeeding (HCR)

• Registration Number: NCT04966858
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-19
• Study Start: 2021-10-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2024-11-30
• Study Completion: 2026-04-14

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 74

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Caloric Refeeding (ICR)	Individualized Caloric Refeeding (ICR)	Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal
Higher Calorie Refeeding (HCR)	Higher Calorie Refeeding (HCR)	Starting 2000 kcal/d, increasing by 200 kcal/d to goal

Primary Outcome Measures

Name	Time	Method
Time to Achieve Medical Stability in Hospital	Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of low serum electrolytes during refeeding in hospital	Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks	Incidence of low electrolytes will be defined as: (1) hypophosphatemia less than 3 milligrams per deciliter (mg/dL), (2) hypomagnesaemia less than 1.8 mg/dL, and (3) hypokalemia less than 3.5 milliequivalent per liter (mEq/L) during hospitalization.

Trial Locations

Locations (2)

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