[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04966858":3,"trial-entities:NCT04966858":100,"trial-summary:NCT04966858":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":45,"secondary_outcomes":50,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":70,"locations":73,"central_contacts":90,"overall_officials":91,"references":98,"see_also_links":99},"NCT04966858","2R01HD082166-06A1","Individualized Study of Refeeding to Optimize iNpatient Gains","Renewal of the Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa","ENROLLING_BY_INVITATION","2026-03-31","2026-01","2026-01-23","2021-10-12","University of California, San Francisco","OTHER",true,"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.","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).\n\nThe 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.\n\nDesign 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.",[19],"Atypical Anorexia Nervosa",[21,22,23,24],"Malnutrition","Refeeding","Nutritional Rehabilitation","Adolescent Medicine","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},74,"ESTIMATED",[33,39],{"type":14,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"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",[34],[38],"ICR",{"type":14,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"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",[40],[44],"HCR",[46],{"measure":47,"description":48,"timeFrame":49},"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\u002Fmin 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\u002Fmin or less, (5) orthostatic change in systolic blood pressure of 20 mmHg or less.","Inpatient hospitalization from day of admission to day of discharge, average 1-2 weeks",[51],{"measure":52,"description":53,"timeFrame":49},"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\u002FdL), (2) hypomagnesaemia less than 1.8 mg\u002FdL, and (3) hypokalemia less than 3.5 milliequivalent per liter (mEq\u002FL) during hospitalization.","ALL","12 Years","24 Years",false,{"inclusion":59,"exclusion":63,"raw_text":69},[60,61,62],"Age 12-24 yrs","Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN","Hospitalized with medical instability, as defined by:",[64,65,66,67,68],"Bulimia nervosa","Current pregnancy","Chronic disease (e.g. immune, renal disease)","Acute\u002Factive suicidality or psychosis","Hospital admissions for refeeding in the prior 6 mo.","Inclusion Criteria:\n\n* Age 12-24 yrs\n* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN\n* Hospitalized with medical instability, as defined by:\n\n  1. night time heart rate (HR) \\\u003C45 bpm,\n  2. systolic blood pressure (SBP) \\\u003C90 mmHg,\n  3. temperature \\\u003C35.6° C,\n  4. orthostatic Δ HR \\>35 bpm, or\n  5. orthostatic Δ SBP \\>20 mmHg\n\nExclusion Criteria:\n\n* Bulimia nervosa\n* Current pregnancy\n* Chronic disease (e.g. immune, renal disease)\n* Acute\u002Factive suicidality or psychosis\n* Hospital admissions for refeeding in the prior 6 mo.",[71,72],"CHILD","ADULT",[74,83],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Stanford University Lucille Packard Children's Hospital","Palo Alto","California","94304","United States",{"lat":81,"lon":82},37.44188,-122.14302,{"facility":84,"city":85,"state":77,"zip":86,"country":79,"geoPoint":87},"University of California, San Francisco Benioff Children's Hospital","San Francisco","94158",{"lat":88,"lon":89},37.77493,-122.41942,[],[92,95],{"name":93,"affiliation":13,"role":94},"Andrea K Garber, RD, PhD","PRINCIPAL_INVESTIGATOR",{"name":96,"affiliation":97,"role":94},"Neville H Golden, MD","Stanford University",[],[],{"nct_id":4,"conditions":101,"biomarkers":103},[102,21],"Atypical anorexia nervosa",[],{"nct_id":4,"found":15,"summary":105,"prompt_version":115},{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional study comparing two different refeeding methods. It plans to enroll 74 participants.","completed","Individualized Caloric Refeeding for Atypical Anorexia Nervosa","This study is comparing two ways to help hospitalized patients with atypical anorexia nervosa (AAN) regain their health. AAN is a condition where people experience significant weight loss and malnutrition but are at a 'normal' weight. The study is testing Individualized Caloric Refeeding (ICR) against the current standard, Higher Calorie Refeeding (HCR). ICR starts with calories based on body weight and increases daily, while HCR starts at 2000 calories and increases daily. The main goal is to see which method helps patients become medically stable faster in the hospital. You might be able to join if you are 12-24 years old, have AAN, and are medically unstable. The study aims to enroll 74 participants.","The study will follow participants for clinical remission over one year after hospitalization.",114,"Not specified in the trial record.","Not stated in the trial record.",[34,40],"v2"]