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Individualized vs High-Calorie Refeeding for Anorexia Nervosa (i-STRONG Trial)

N/A
Waitlist Available
Led By Andrea K Garber, RD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 12-24 years
Must not have
Acute/active suicidality or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-study hospitalization
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two ways of feeding patients with AAN to see which is more effective and has fewer side effects.

Who is the study for?
This trial is for hospitalized youths aged 12-24 with atypical anorexia nervosa, who meet specific health criteria like low heart rate or blood pressure. It's not for those with bulimia, recent refeeding hospital stays, chronic diseases, pregnancy, or acute mental health crises.
What is being tested?
The study compares Individualized Caloric Refeeding (ICR) to Higher Calorie Refeeding (HCR), focusing on safety and how well they work in treating patients with atypical anorexia nervosa over a year of follow-up.
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort, metabolic changes, and psychological distress due to the change in diet and caloric intake during the refeeding process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am hospitalized with unstable health due to very low heart rate, blood pressure, or body temperature.
Select...
I am between 12 and 24 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently experiencing thoughts of harming myself or others, nor am I experiencing a break from reality.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-study hospitalization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-study hospitalization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Achieve Medical Stability in Hospital
Secondary study objectives
Incidence of low serum electrolytes during refeeding in hospital
Other study objectives
Eating Disorder Examination Questionnaire (EDE-Q) Score Over 12 Months
Percentage median BMI (mBMI) Over 12 Months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized Caloric Refeeding (ICR)Experimental Treatment1 Intervention
Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal
Group II: Higher Calorie Refeeding (HCR)Active Control1 Intervention
Starting 2000 kcal/d, increasing by 200 kcal/d to goal

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,591 Previous Clinical Trials
14,901,519 Total Patients Enrolled
5 Trials studying Anorexia
478 Patients Enrolled for Anorexia
Stanford UniversityOTHER
2,484 Previous Clinical Trials
17,516,047 Total Patients Enrolled
14 Trials studying Anorexia
1,281 Patients Enrolled for Anorexia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,061 Previous Clinical Trials
2,745,114 Total Patients Enrolled
4 Trials studying Anorexia
367 Patients Enrolled for Anorexia
Andrea K Garber, RD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Neville H Golden, MDPrincipal InvestigatorStanford University

Media Library

Higher Calorie Refeeding (HCR) Clinical Trial Eligibility Overview. Trial Name: NCT04966858 — N/A
Anorexia Research Study Groups: Individualized Caloric Refeeding (ICR), Higher Calorie Refeeding (HCR)
Anorexia Clinical Trial 2023: Higher Calorie Refeeding (HCR) Highlights & Side Effects. Trial Name: NCT04966858 — N/A
Higher Calorie Refeeding (HCR) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04966858 — N/A
~18 spots leftby Dec 2025
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