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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00946361
Other study ID # IRB09-00036
Secondary ID
Status Terminated
Phase N/A
First received July 24, 2009
Last updated May 14, 2015
Start date July 2009
Est. completion date May 2010

Study information

Verified date July 2009
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The investigators will prospectively recruit 26 children with moderate - severe active Crohn disease (PCDAI >30). Results will be compared to 26 patients in sustained remission (PCDAI <10 and physician global assessment of remission over the previous 6 months) who are matched for age and gender. Subjects will be studied at baseline and six months. The primary study end-points will be leucine rate of appearance (a measure of protein breakdown) and IGF-1 levels.

This study will test the hypothesis that children with greater disease severity will have worse longitudinal growth and protein catabolism. The investigators will also explore the secondary hypothesis that children with Crohn disease have abnormal IGF-1 generation which is linked to underlying inflammation and disease severity.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria:

- Diagnosed with Crohn disease by endoscopy and histologic samples

- Chronological and/or bone age 6-15 years old

- Tanner 1 - 2

- Willing to participate in our longitudinal evaluation

Exclusion Criteria:

- Concomitant persistent chronic infectious disease

- Inflammatory bowel disease not diagnosed as Crohn disease

- Immunological disorder (excluding Crohn disease)

- Associated severe concomitant chronic illnesses (CF, liver failure)

- Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Examinations
Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Height velocity 6 months No
Secondary Protein catabolism 6 months No
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