Individualized Study of Refeeding to Optimize iNpatient Gains

Atypical Anorexia Nervosa Clinical Trial

— i-STRONG  

Official title:

Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04966858
• Other study ID #: 2R01HD082166-06A1
• Secondary ID: 20-32551R01HD082
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: April 14, 2026

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 74
• Est. completion date: April 14, 2026
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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 ? HR >35 bpm, or

5. orthostatic ? 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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Atypical Anorexia Nervosa

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Stanford University Lucille Packard Children's Hospital	Palo Alto	California
United States	University of California, San Francisco Benioff Children's Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage median BMI (mBMI) Over 12 Months	Measured BMI will be divided by the mBMI for age and sex per national growth data to give the percentage mBMI.	12 months post-study hospitalization
Other	Eating Disorder Examination Questionnaire (EDE-Q) Score Over 12 Months	The EDE-Q will be self-administered; scores range from 1 to 6, with higher scores indicating greater severity and a worse outcome.	12 months post-study hospitalization
Primary	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	Incidence of low serum electrolytes during refeeding in hospital	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.	Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks