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

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ClinicalTrials.gov Identifier: NCT04966858
Recruitment Status : Not yet recruiting
First Posted : July 19, 2021
Last Update Posted : August 23, 2021
Sponsor:
Collaborators:
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Atypical Anorexia Nervosa Other: Individualized Caloric Refeeding (ICR) Other: Higher Calorie Refeeding (HCR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
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.
Primary Purpose: Treatment
Official Title: Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : April 14, 2026

Arm Intervention/treatment
Experimental: Individualized Caloric Refeeding (ICR)
Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal
Other: Individualized 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
Other Name: ICR

Active Comparator: Higher Calorie Refeeding (HCR)
Starting 2000 kcal/d, increasing by 200 kcal/d to goal
Other: Higher 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
Other Name: HCR




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of low serum electrolytes during refeeding in hospital [ Time Frame: 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.


Other Outcome Measures:
  1. Percentage median BMI (mBMI) Over 12 Months [ Time Frame: 12 months post-study hospitalization ]
    Measured BMI will be divided by the mBMI for age and sex per national growth data to give the percentage mBMI.

  2. Eating Disorder Examination Questionnaire (EDE-Q) Score Over 12 Months [ Time Frame: 12 months post-study hospitalization ]
    The EDE-Q will be self-administered; scores range from 1 to 6, with higher scores indicating greater severity and a worse outcome.



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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966858


Contacts
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Contact: Andrea Garber, PHD, RD 415-514-2180 andrea.garber@ucsf.edu
Contact: Siena Vendlinski, BS 510-928-9368 siena.vendlinski@ucsf.edu

Locations
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United States, California
Stanford University Lucille Packard Children's Hospital
Palo Alto, California, United States, 94304
Contact: Neville H Golden, MB, MD    650-736-9557    ngolden@stanford.edu   
Contact: Anna Kreiter, PsyD       akreiter@stanford.edu   
Principal Investigator: Neville H Golden, MB, MD         
University of California, San Francisco Benioff Children's Hospital
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Andrea K Garber, RD, PhD University of California, San Francisco
Principal Investigator: Neville H Golden, MD Stanford University
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04966858    
Other Study ID Numbers: 2R01HD082166-06A1 ( U.S. NIH Grant/Contract )
20-32551 ( Other Identifier: UCSF IRB )
R01HD082166 ( U.S. NIH Grant/Contract )
HD082166 ( Other Identifier: Federal Identifier, per NIH application )
P0547076 ( Other Identifier: NIH Application Identifier )
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Malnutrition
Refeeding
Nutritional Rehabilitation
Adolescent Medicine
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders