Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338221
Status:
WITHDRAWN
Last Update Posted:
2008-10-28
First Post:
2006-06-15
Brief Title:
Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
Status:
WITHDRAWN
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function measured by lactulosemannitol test on day 8 in children at HIAS in Fortaleza Ce Brazil with persistent diarrhea history 2 weeks duration or malnutrition
Detailed Description:
This is a double blinded randomized clinical trial of Alanyl-Glutamine or Glycine in children with persistent diarrhea or malnutrition The primary objective of the study is to determine the effect of 7 days of supplementation of alanyl-glutamine as it compares to glycine on the damaged intestinal barrier function measured by lactulosemannitol test on day 8 in children at HIAS in Fortaleza Ce Brazil with persistent diarrhea history 2 weeks duration or malnutrition assessed by height-for-age Z-score less than -1 Secondary objectives of the study include determining the effect of 7 days of supplementation of alanyl-glutamine or glycine on diarrhea frequency and duration weight gain protein loss and intestinal inflammation and lactoferrin excretion and weight gain at 2-4 weeks after treatment One hundred and eight children who meet the inclusion criteria will be prospectively randomized to one of two treatment groups 1 Glycine or 2 Alanyl-Glutamine All children will be given vitamin A and Zinc supplementation and if they have diarrhea standard oral or IV rehydration therapy will be administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None