Summary

Eligibility
for people ages 12-24 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Andrea K Garber

Description

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.

Official Title

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

Details

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.

Keywords

Atypical Anorexia Nervosa Malnutrition Refeeding Nutritional Rehabilitation Adolescent Medicine Anorexia Anorexia Nervosa Individualized Caloric Refeeding (ICR) Higher Calorie Refeeding (HCR)

Eligibility

You can join if…

Open to people ages 12-24

  • 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 CAN'T join 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.

Locations

  • University of California, San Francisco Benioff Children's Hospital
    San Francisco California 94158 United States
  • Stanford University Lucille Packard Children's Hospital
    Palo Alto California 94304 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04966858
Study Type
Interventional
Last Updated