Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 77
- Locations
- 2
- Primary Endpoint
- Time to Achieve Medical Stability in Hospital
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Treatments are not to be blinded, since both the patients and clinicians who work with this population are highly skilled at estimating kcal and would be able to determine group assignment by simply viewing meal trays.
Eligibility Criteria
- Ages
- 12 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
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.
Arms & Interventions
Higher Calorie Refeeding (HCR)
Starting 2000 kcal/d, increasing by 200 kcal/d to goal
Intervention: Higher Calorie Refeeding (HCR) (Other)
Individualized Caloric Refeeding (ICR)
Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal
Intervention: Individualized Caloric Refeeding (ICR) (Other)
Outcomes
Primary Outcomes
Time to Achieve Medical Stability in Hospital
Time Frame: 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 Outcomes
- 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 serum electrolytes during refeeding in hospital(Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks)