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NCT00583232 · ClinicalTrials.gov registry record · Phase 1
Protein and Energy Metabolism in Pediatric Crohn's Disease
A Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00583232 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 15 participants.
The verdict
NCT00583232, a Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has been incriminated in the mechanism of weight loss in many different chronic diseases, and causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven to be an effective therapy for ulcerative colitis. The purpose of this study is to compare changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this study will better define the changes in nutrition status observed in these children following remission of active Crohn's disease, and potentially lead to changes in medical and nutritional management of these children.
Interventions
- DRUG Stable isotope infusions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00583232
The ClinicalTrials.gov registry entry for NCT00583232 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Stable isotope infusions is the first listed.
NCT00583232 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00583232 about?
NCT00583232 is a clinical study titled "Protein and Energy Metabolism in Pediatric Crohn's Disease". The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and changes in energy expenditure, plays a significant role in the resulting malnutrition from which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine, has been found to...
What is the current status of trial NCT00583232?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2006-02. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00583232?
The interventions under investigation include: Stable isotope infusions (DRUG).
Who is sponsoring clinical trial NCT00583232?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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