Anorexia NervosaNCT00942929
Lung Function Tests in Adolescents With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Dec 2009
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents 12-18 years old hospitalized to a pediatric ward
Who may be able to join
- Adolescents with anorexia nervosa
- Ability to preform lung function tests
- Parents signing informed concent and adolescents signing informed ascent
Who cannot join
- A history of a lung disease
- Intercurrent lung illness
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Centre, Department of Pediatrics
Haifa, 31048
Nogah C Kerem, MD, 972-4-8359662, nogah.kerem@b-zion.org.il
Amir Kugelman, MD, 972-4-8359559, dramir@netvision.net.il
About this study
The investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.
Read the detailed description
Anorexia Nervosa in adolescents holds adverse effects on different body systems as the cardiovascular, central nervous, endocrine, bone and gastrointestinal systems. There is paucity of information regarding the adverse effects of this tenacious illness on the lungs of adolescents at the hypocaloric stage of their illness. Based on previous clinical observations we postulate that lung function tests would be adversely effected by the hypocaloric nutrition of adolescents with anorexia nervosa and that they may improve during short refeeding in an inpatient setting of a general pediatric ward. To examine our hypothesis we would check lung function by various parameters of adolescents suffering from AN and a control group of adolescents.
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, adolescents, lung function tests, refeeding
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents hospitalized for anorexia nervosa | Adolescent 12-18 years old, fulfilling the DSM IV criteria for anorexia nervosa, hospitalized for medical stabilization and/ or initiation of refeeding | |
| Controls | Adolescents 12-18 years old without anorexia nervosa hospitalized for reasons other than those involving the respiratory system and with no underlying lung disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function tests at admission of adolescents with anorexia nervosa
Measured: On addmission to the pediatric ward
Secondary outcomes (1)
Lung function tests at discharge of adolescents with anorexia nervosa
Measured: On discharge from the pediatric ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startSep 2008
- Study completionDec 2009 (estimated)
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.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942929
- Sponsor's protocol ID
- 48/08
- Status last verified
- Jul 2009
- First submitted
- 20 Jul 2009
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function Tests in Adolescents With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00942929
- Acronym / sponsor ID
- 48/08
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, adolescents, lung function tests, refeeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Sep 2008
- Study completion
- Dec 2009 (estimated)
- First posted
- 21 Jul 2009 (estimated)
- 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 investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.
Detailed description
Anorexia Nervosa in adolescents holds adverse effects on different body systems as the cardiovascular, central nervous, endocrine, bone and gastrointestinal systems. There is paucity of information regarding the adverse effects of this tenacious illness on the lungs of adolescents at the hypocaloric stage of their illness. Based on previous clinical observations we postulate that lung function tests would be adversely effected by the hypocaloric nutrition of adolescents with anorexia nervosa and that they may improve during short refeeding in an inpatient setting of a general pediatric ward. To examine our hypothesis we would check lung function by various parameters of adolescents suffering from AN and a control group of adolescents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents hospitalized for anorexia nervosa | – | –Adolescent 12-18 years old, fulfilling the DSM IV criteria for anorexia nervosa, hospitalized for medical stabilization and/ or initiation of refeeding |
| Controls | – | –Adolescents 12-18 years old without anorexia nervosa hospitalized for reasons other than those involving the respiratory system and with no underlying lung disease |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents 12-18 years old hospitalized to a pediatric ward
Key inclusion criteria (3 listed)
- Adolescents with anorexia nervosa
- Ability to preform lung function tests
- Parents signing informed concent and adolescents signing informed ascent
Key exclusion criteria (2 listed)
- A history of a lung disease
- Intercurrent lung illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung function tests at admission of adolescents with anorexia nervosa
Time frame: On addmission to the pediatric ward
1 secondary outcome
Lung function tests at discharge of adolescents with anorexia nervosa
Time frame: On discharge from the pediatric ward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2009.
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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.
Bnai Zion Medical Centre, Department of Pediatrics
Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Bnai Zion Medical Center at 1 site in Israel.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function tests at admission of adolescents with anorexia nervosa (time frame: On addmission to the pediatric ward). 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 21 Jul 2009; AzTrials last refreshed its copy on 30 Oct 2026.