Individualized Study of Refeeding to Optimize iNpatient Gains (i-STRONG)

University of California San Francisco (UCSF)

Status: Invitation-only

Conditions: Atypical Anorexia Nervosa

Treatments: Other: Higher Calorie Refeeding (HCR); Other: Individualized Caloric Refeeding (ICR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04966858

P0547076 (Other Identifier)

R01HD082166 (U.S. NIH Grant/Contract)

2R01HD082166-06A1

20-32551 (Other Identifier)

HD082166 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Individualized Caloric Refeeding (ICR)

Experimental group

Description:

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

Treatment:

Other: Individualized Caloric Refeeding (ICR)

Higher Calorie Refeeding (HCR)

Active Comparator group

Description:

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

Treatment:

Other: Higher Calorie Refeeding (HCR)