Clinical trial NCT04966858: Individualized Study of Refeeding to Optimize iNpatient Gains
Official title: Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Atypical Anorexia Nervosa
Keywords: Malnutrition
Refeeding
Nutritional Rehabilitation
Adolescent Medicine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be recruited upon hospital admission at the University of California, San Francisco (UCSF) and Stanford and randomly assigned to Individualized Caloric Refeeding (ICR) or Higher Calorie Refeeding (HCR) for the duration of the hospitalization. Treatment ends at hospital discharge with open follow-up for one year. Participants followed daily in hospital and at 3mo, 6mo, 9mo, and 12mo post-discharge.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Achieve Medical Stability in Hospital
timeFrame: Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks
Secondary outcomes:
measure: Incidence of low serum electrolytes during refeeding in hospital
timeFrame: Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks
Other outcomes:
measure: Percentage median BMI (mBMI) Over 12 Months
timeFrame: 12 months post-study hospitalization
measure: Eating Disorder Examination Questionnaire (EDE-Q) Score Over 12 Months
timeFrame: 12 months post-study hospitalization
Locations:
city: Palo Alto
country: United States
facility: Stanford University Lucille Packard Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Benioff Children's Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andrea K Garber, RD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Neville H Golden, MD
role: PRINCIPAL_INVESTIGATOR
References: