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NCT00586807 · ClinicalTrials.gov registry record · NA
Metabolic Response to Infliximab in Pediatric Ulcerative Colitis
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT00586807: Clinical Trial NA study, sponsored by Indiana University.
NCT00586807 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00586807, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The metabolic response to ulcerative colitis, 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 determine changes in protein and lipid metabolism, as well as resting energy expenditure, before and after therapy with anti-TNF-alpha antibody (infliximab) in children with ulcerative colitis. Performing this study will better define the changes in nutrition status observed in these children following remission of active ulcerative colitis, and potentially lead to changes in medical and nutritional management of these children
Interventions
- OTHER Stable amino acid isotopes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-09 |
| Phase | NA |
Why NCT00586807 stopped before completion
NCT00586807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Stable amino acid isotopes is the first listed.
NCT00586807 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00586807 about?
NCT00586807 is a clinical study titled "Metabolic Response to Infliximab in Pediatric Ulcerative Colitis". The metabolic response to ulcerative colitis, 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...
What is the current status of trial NCT00586807?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2005-06. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00586807?
The interventions under investigation include: Stable amino acid isotopes (OTHER).
Who is sponsoring clinical trial NCT00586807?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00586807's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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