Lung Function Tests in Adolescents With Anorexia Nervosa | NCT00942929

Studies
Lung Function Tests in Adolescents With Anorexia Nervosa

NCT00942929

Sponsor

Bnai Zion Medical Center

Status

Unknown status

Last Update Posted

Jul 21, 2009Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Not provided

Completion Date

Dec 2009Estimated

First Submitted Date

Jul 20, 2009

First Submission Date that Met QC Criteria

Jul 20, 2009

First Posted Date

Jul 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2009

Last Update Posted Date

Jul 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung function tests at admission of adolescents with anorexia nervosa		On addmission to the pediatric ward

Secondary Outcomes

Measure	Description	Time Frame
Lung function tests at discharge of adolescents with anorexia nervosa		On discharge from the pediatric ward

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Adolescents 12-18 years old hospitalized to a pediatric ward

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion Medical Centre, Department of Pediatrics	Recruiting	Haifa		31048	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

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