Status:
WITHDRAWN
Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Diarrhea, Malnutrition
Eligibility:
All Genders
3-36 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for \> 2 weeks or height-for-age Z-score (HAZ) less than -1, which is the median of HAZ scores in children at HIAS.
- Be an inpatient and willing to stay for 7 nights at HIAS.
- Child's parent or guardian must sign informed consent.
Exclusion
- Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
- Children who participated in the "community study" or any other study within the past two years (Reason: The children in the "community study" will have received glutamine.)
- Children with suspected other illnesses as indicated by fever \>102 degrees F at time of screening off antipyretics.
- Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
- Severe malnutrition defined as HAZ \<-3.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00338221
Start Date
August 1 2004
End Date
April 1 2005
Last Update
October 28 2008
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