Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition

Sponsor

University of Virginia (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00338221

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

108

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Diarrhea, Malnutrition	Drug: alanyl-glutamine Drug: glycine	Phase 3

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 lactulose/mannitol 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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition

Study Start Date :

Aug 1, 2004

Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: Richard L Guerrrant, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00338221

Other Study ID Numbers:

02-039

First Posted:

Jun 20, 2006

Last Update Posted:

Oct 28, 2008

Last Verified:

Oct 1, 2008

Keywords provided by , ,

Diarrhea, Malnutrition, Brazil

Additional relevant MeSH terms:

Malnutrition

Diarrhea

Glycine

Study Results

No Results Posted as of Oct 28, 2008