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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 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 10 participants.

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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

FieldValue
Enrollment Target 10 participants
Start Date 2005-06
Est. Completion 2008-09
Phase NA

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT00586807

The ClinicalTrials.gov registry entry for NCT00586807 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 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 amino acid isotopes is the first listed.

NCT00586807 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.