Anorexia NervosaNCT03334032
Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Charite University, Berlin, Germany.
Trial summary
The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Inpatient treatment for Anorexia nervosa
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: At baseline assessment, ten patients had primary amenorrhea and 87 girls secondary amenorrhea. Six girls were not amenorrhoeic but were taking oral contraceptives or had lost more than 20% of their weight and fulfilled the remaining diagnostic criteria for AN. The mean duration of the eating disorder at the time of testing was 15 ± 12 months, ranging from 3 to 60 months and estimated premorbid BMI of the AN patients was 20.4 ± 2.9 (13.5 - 28.7 kg/m2; data available for 98 patients). Before admission, the patients (n = 97) had lost 15 ± 7 (2 - 36) kg. The mean weight on hospital admission (data available for 88 patients; 10 patients were outpatients; missing data, n = 5) was 41.1 ± 6.1 kg.
Patient Inclusion Criteria:
- diagnosis of anorexia nervosa (DSM-IV)
- aged 12 - 19 years
- female gender
Patient Exclusion Criteria:
- existence of a further disease with effect on body composition
Controls:
- no known disease
- normal weight
About this study
The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa
Read the detailed description
Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.
Objective: The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.
Methods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.
- Conditions
- Anorexia Nervosa
- Being tested
- Inpatient treatment for Anorexia nervosa
- Keywords
- Body composition, Total body protein, nutritional recovery, Exercise status, In-vivo neutron activation analysis, Protein depletion
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient treatment for Anorexia nervosaOther
Nutritional rehabilitation in a clinic with specialized eating disorder service
| Study group | Role | What they receive |
|---|---|---|
| Inpatient treatment for Anorexia nervosa | Adolescents with anorexia nervosa assessed
1. at baseline: on admission to inpatient treatment
2. at follow-up: 6 months after admission on outpatient basis Receives: Other: Inpatient treatment for Anorexia nervosa | |
| Controls | Adolescent healthy and normal weight controls (matched for gender and age), assessed at one point of time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Body protein
Change in Total Body protein
Measured: Between baseline (inpatient admission) and at 7 months follow-up
Secondary outcomes (4)
Change in body weight
Change in: body weight (kg)
Measured: Between baseline (inpatient admission) and at 7 months follow-up
Change in Body Mass Index
Change in Body Mass Index (BMI; kg/m2)
Measured: Between baseline (inpatient admission) and at 7 months follow-up
Change in body fat mass
Change in body fat mass (kg)
Measured: Between baseline (inpatient admission) and at 7 months follow-up
Change in body lean tissue mass
Change in body lean tissue mass (kg)
Measured: Between baseline (inpatient admission) and at 7 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startJul 2004
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Dr. Verena Haas, Charite University, Berlin, Germany
- Investigators
- Michael R Kohn, Prof., Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334032
- Sponsor's protocol ID
- TBN in AN
- Status last verified
- Nov 2017
- First submitted
- 29 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03334032
- Acronym / sponsor ID
- TBN in AN
- Conditions
- Anorexia Nervosa
- Keywords
- Body composition, Total body protein, nutritional recovery, Exercise status, In-vivo neutron activation analysis, Protein depletion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- Jul 2004 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to assess protein accretion during weight gain in adolescent patients with Anorexia nervosa
Detailed description
Background: Bone health and growth during adolescence require adequate Total Body Protein (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body composition, i.e. recovery of fat mass and TBPr.
Objective: The study intended to analyze predictors of protein status, including exercise status, in adolescents with AN, and to investigate whether weight gain would replete body protein deficits.
Methods: The investigators assessed TBPr in a longitudinal, observational study as height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and in age-matched normal weight controls. Lean tissue and fat mass were assessed with Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as predictors of protein status using Receiver Operating Characteristic (ROC) analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient treatment for Anorexia nervosa | – | Other: Inpatient treatment for Anorexia nervosaAdolescents with anorexia nervosa assessed 1. at baseline: on admission to inpatient treatment 2. at follow-up: 6 months after admission on outpatient basis |
| Controls | – | –Adolescent healthy and normal weight controls (matched for gender and age), assessed at one point of time |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- At baseline assessment, ten patients had primary amenorrhea and 87 girls secondary amenorrhea. Six girls were not amenorrhoeic but were taking oral contraceptives or had lost more than 20% of their weight and fulfilled the remaining diagnostic criteria for AN. The mean duration of the eating disorder at the time of testing was 15 ± 12 months, ranging from 3 to 60 months and estimated premorbid BMI of the AN patients was 20.4 ± 2.9 (13.5 - 28.7 kg/m2; data available for 98 patients). Before admission, the patients (n = 97) had lost 15 ± 7 (2 - 36) kg. The mean weight on hospital admission (data available for 88 patients; 10 patients were outpatients; missing data, n = 5) was 41.1 ± 6.1 kg.
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 |
|---|---|---|
| Inpatient treatment for Anorexia nervosaNutritional rehabilitation in a clinic with specialized eating disorder service | Other | Inpatient treatment for Anorexia nervosa |
Primary outcome
Change in Total Body protein
Time frame: Between baseline (inpatient admission) and at 7 months follow-up
Change in Total Body protein
4 secondary outcomes
Change in body weight
Time frame: Between baseline (inpatient admission) and at 7 months follow-up
Change in Body Mass Index
Time frame: Between baseline (inpatient admission) and at 7 months follow-up
Change in body fat mass
Time frame: Between baseline (inpatient admission) and at 7 months follow-up
Change in body lean tissue mass
Time frame: Between baseline (inpatient admission) and at 7 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Michael R Kohn, Prof. principal investigator
University of Sydney
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Charite University, Berlin, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Total Body protein (time frame: Between baseline (inpatient admission) and at 7 months follow-up). 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 7 Nov 2017.