Atypical Anorexia Nervosa
Conditions
Keywords
Malnutrition, Refeeding, Nutritional Rehabilitation, Adolescent Medicine
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.
Interventions
OTHERIndividualized 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
OTHERHigher 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
Sponsors
University of California, San Francisco
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
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.
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Medical Stability in Hospital | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea K Garber, RD, PhD
University of California, San Francisco
PRINCIPAL_INVESTIGATORNeville H Golden, MD
Stanford University
Outcome results
None listed