Atypical Anorexia Nervosai-STRONGNCT04966858
Individualized Study of Refeeding to Optimize iNpatient Gains
A study testing Individualized Caloric Refeeding (ICR) and Higher Calorie Refeeding (HCR) in people with Atypical Anorexia Nervosa, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Atypical Anorexia Nervosa
- What is being tested?
- Individualized Caloric Refeeding (ICR) and Higher Calorie Refeeding (HCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2021to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University Lucille Packard Children's Hospital
Palo Alto, California, 94304
University of California, San Francisco Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
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.
Read the 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.
- Conditions
- Atypical Anorexia Nervosa
- Being tested
- Individualized Caloric Refeeding (ICR), Higher Calorie Refeeding (HCR)
- Keywords
- Malnutrition, Refeeding, Nutritional Rehabilitation, Adolescent Medicine
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Caloric Refeeding (ICR)Other
Also called 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
Higher Calorie Refeeding (HCR)Other
Also called HCR
Meal-based refeeding in hospital, starting at 2000 calories per day, and increasing by 200 calories per day until caloric goal achieved
| Study group | Role | What they receive |
|---|---|---|
| Individualized Caloric Refeeding (ICR) | Experimental | Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal Receives: Other: Individualized Caloric Refeeding (ICR) |
| Higher Calorie Refeeding (HCR) | Active comparator | Starting 2000 kcal/d, increasing by 200 kcal/d to goal Receives: Other: Higher Calorie Refeeding (HCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Medical Stability in Hospital
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.
Measured: Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks
Secondary outcomes (1)
Incidence of Low Serum Electrolytes During Refeeding in Hospital
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.
Measured: Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start12 Oct 2021
- Primary completion3 Jun 2025
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atypical Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Andrea K Garber, PhD, RD, Principal investigator, University of California, San FranciscoNeville H Golden, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966858
- Sponsor's protocol ID
- 2R01HD082166-06A1
- Other IDs
- 20-32551, R01HD082166, HD082166, P0547076
- Acronym
- i-STRONG
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2021
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04966858
- Acronym / sponsor ID
- i-STRONG / 2R01HD082166-06A1
- Conditions
- Atypical Anorexia Nervosa
- Keywords
- Malnutrition, Refeeding, Nutritional Rehabilitation, Adolescent Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 25 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized Caloric Refeeding (ICR) | Experimental | Other: Individualized Caloric Refeeding (ICR)Starting 50 kcal/kg/d, increasing by 200 kcal/d to goal |
| Higher Calorie Refeeding (HCR) | Active comparator | Other: Higher Calorie Refeeding (HCR)Starting 2000 kcal/d, increasing by 200 kcal/d to goal |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 12-24 yrs
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN
- Hospitalized with medical instability, as defined by:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Caloric Refeeding (ICR)Also: ICRMeal-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 | Individualized Caloric Refeeding (ICR) |
| Higher Calorie Refeeding (HCR)Also: HCRMeal-based refeeding in hospital, starting at 2000 calories per day, and increasing by 200 calories per day until caloric goal achieved | Other | Higher Calorie Refeeding (HCR) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea K Garber, PhD, RD principal investigator
University of California, San Francisco
Neville H Golden, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Caloric Refeeding (ICR) and Higher Calorie Refeeding (HCR) in people with Atypical Anorexia Nervosa, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve Medical Stability in Hospital (time frame: Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.