Status:
WITHDRAWN
HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Diarrhea, Malnutrition
Other Nutritional Deficiencies
Eligibility:
All Genders
3-3 years
Phase:
PHASE3
Brief Summary
This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or malnutrition.
Detailed Description
The purpose of this study is to determine the effect of 7 days supplementation of alanyl-glutamine or glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, ...
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 negative 1, which is the median of HAZ score 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 \>102º 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 or WAZ \<-3.5 or any child weighing \<10 lbs. (4.5 kg) or any child with a weight-to-height ratio \<60% of the NCHS age adjusted norm.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00133562
Start Date
August 1 2004
End Date
May 1 2006
Last Update
October 28 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.