- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942929
Lung Function Tests in Adolescents With Anorexia Nervosa
July 20, 2009 updated by: Bnai Zion Medical Center
The investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haifa, Israel, 31048
- Recruiting
- Bnai Zion Medical Centre, Department of Pediatrics
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Contact:
- Nogah C Kerem, MD
- Phone Number: 972-4-8359662
- Email: nogah.kerem@b-zion.org.il
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Contact:
- Amir Kugelman, MD
- Phone Number: 972-4-8359559
- Email: dramir@netvision.net.il
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Principal Investigator:
- Nogah C Kerem, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adolescents 12-18 years old hospitalized to a pediatric ward
Description
Inclusion Criteria:
- Adolescents with anorexia nervosa
- Ability to preform lung function tests
- Parents signing informed concent and adolescents signing informed ascent
Exclusion Criteria:
- A history of a lung disease
- Intercurrent lung illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lung function tests at admission of adolescents with anorexia nervosa
Time Frame: On addmission to the pediatric ward
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On addmission to the pediatric ward
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lung function tests at discharge of adolescents with anorexia nervosa
Time Frame: On discharge from the pediatric ward
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On discharge from the pediatric ward
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
July 20, 2009
First Submitted That Met QC Criteria
July 20, 2009
First Posted (Estimate)
July 21, 2009
Study Record Updates
Last Update Posted (Estimate)
July 21, 2009
Last Update Submitted That Met QC Criteria
July 20, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 48/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.