Crohns DiseaseNCT00946361
Impaired Insulin-like Growth Factor-1 (IGF-1) Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
An observational study of Crohns Disease, run by Nationwide Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Crohns Disease
- What is being tested?
- Examinations
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: GI clinic patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
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.
- Conditions
- Crohns Disease
- Being tested
- Examinations
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaminationsOther
Growth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Not described Receives: Other: Examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height velocity
Measured: 6 months
Secondary outcomes (1)
Protein catabolism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana S Hardin, MD, Principal investigator, The Research Institute at Nationwide Children's Hospital, The Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946361
- Sponsor's protocol ID
- IRB09-00036
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired IGF-1 Generation Causes Protein Catabolism and Poor Growth in Children With Crohn Disease
- ClinicalTrials.gov ID
- NCT00946361
- Acronym / sponsor ID
- IRB09-00036
- Conditions
- Crohns Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | – | Other: Examinations |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- GI clinic patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ExaminationsGrowth hormone stimulation testing, Protein turnover, Dexa scan, Bone age x-ray | Other | Diagnostic |
Primary outcome
Height velocity
Time frame: 6 months
1 secondary outcome
Protein catabolism
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
Dana S Hardin, MD principal investigator
The Research Institute at Nationwide Children's Hospital, The Ohio State University
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 Crohns Disease, run by Nationwide Children's Hospital at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 May 2015. 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 United States. 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?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
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?
Height velocity (time frame: 6 months). 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 15 May 2015.