Anorexia Nervosa Clinical Trial
Official title:
Multi Site Randomized Controlled Trial on Refeeding Syndrome in Anorexia Nervosa
NCT number | NCT02621229 |
Other study ID # | IRB-33865 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | November 17, 2015 |
Last updated | October 13, 2016 |
Start date | December 2015 |
The purpose of this multi-center randomized controlled trial is to compare lower calorie refeeding to higher calorie refeeding for hospitalized adolescents and young adults with AN. The investigators will compare efficacy (achievement and maintenance of clinical remission at 12 months), safety during hospitalization, and cost effectiveness (including costs of initial and re hospitalization, 12 month follow up and safety/adverse events).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 24 Years |
Eligibility |
Inclusion Criteria: - Adolescents hospitalized for medical instability secondary to malnutrition will be eligible as follows. Inclusion criteria: 1. diagnosis of AN, atypical AN 2. age 12-24 years 3. no hospital admissions for the previous six months 4. meet hospitalization criteria (daytime HR < 50 bpm or night time HR < 45 bpm, BP <90/45 mmHg, temperature < 36? C or orthostasis defined by increase in HR > 20 bpm or decrease in systolic BP > 20 mmHg or decrease in diastolic BP > 10 mmHg from lying to standing) Exclusion Criteria: 1. diagnosis of bulimia nervosa [DSM-5] 2. current pregnancy 3. admission for food refusal without malnutrition 4. chronic disease (e.g. immune/endocrine disorders,pulmonary, cardiac, or renal disease) 5. current suicidality or psychosis. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical remission defined by weight and medical stability | (i) weight = 95% median BMI (MBMI) for age and sex, and (ii) medical stability during 12 mo follow-up defined by published vital sign thresholds. If both of these conditions are met we will consider the patient in clinical remission. | 12 months | No |
Primary | Incidence of electrolyte inbalances | We will monitor any differences in LCR and HCR by incidence of: 1- hypophosphatemia (=3 mg/dL), 2- hypomagnesaemia (=1.7 mg/dL), and 3- hypokalemia (=3.5 mEq/L). If any of these three conditions occur we will record this as an instance of electrolyte inbalance. | 12 months | Yes |
Primary | Cost of initial and re-hospitalizations | Hospital costs, taking into account number of days in hospital and any extra services performed (blood draws, PICU consults, etc), and any rehospitalization costs. | 12 months | No |
Secondary | Clinical remission defined by psychological recovery | Eating Disorder Examination (EDE) global score within 1 SD of clinical norm | 12 months | No |
Secondary | Cost of 12 mo follow-up and other care | Cost of outpatient visits - including medical, nutrition, and psychological | 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05531604 -
Appetitive Conditioning in Anorexia Nervosa
|
||
Enrolling by invitation |
NCT04174703 -
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
|
N/A | |
Active, not recruiting |
NCT04883554 -
Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study
|
N/A | |
Recruiting |
NCT04213820 -
TMS and Body Image Treatment for Anorexia Nervosa
|
N/A | |
Completed |
NCT03414112 -
The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa
|
Early Phase 1 | |
Recruiting |
NCT06144905 -
Norwegian Microbiota Study in Anorexia Nervosa
|
||
Recruiting |
NCT05803707 -
Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
|
N/A | |
Recruiting |
NCT05682417 -
Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa
|
N/A | |
Not yet recruiting |
NCT06380257 -
Anorexia Nervosa and Brain in Adolescence
|
||
Not yet recruiting |
NCT04804800 -
Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa
|
N/A | |
Not yet recruiting |
NCT03600610 -
Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa
|
N/A | |
Completed |
NCT02745067 -
Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa
|
N/A | |
Completed |
NCT02382055 -
Changing Habits in Anorexia Nervosa: Novel Treatment Development
|
N/A | |
Terminated |
NCT02240797 -
Kappa Opioid Receptor Imaging in Anorexia
|
N/A | |
Completed |
NCT03075371 -
Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa
|
N/A | |
Completed |
NCT03144986 -
Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa
|
N/A | |
Unknown status |
NCT01761942 -
Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa
|
Phase 2 | |
Completed |
NCT01579682 -
Adaptive Family Treatment for Adolescent Anorexia Nervosa
|
N/A | |
Completed |
NCT02551445 -
A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.
|
N/A | |
Completed |
NCT00946816 -
The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
|
N/A |