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HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition

This study has been withdrawn prior to recruitment.

Sponsors and Collaborators: University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: University of Virginia
ClinicalTrials.gov Identifier: NCT00133562
  Purpose

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.


Condition Intervention Phase
Diarrhea, Malnutrition
Other Nutritional Deficiencies
Drug: Alanyl-glutamine
Drug: Glycine
Phase III

MedlinePlus related topics:   Children's Health    Diarrhea   

Drug Information available for:   Glycine    Glutamine    Alanylglutamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Prospective Double Blind Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Hospitalized Children With Persistent Diarrhea or Malnutrition.

Further study details as provided by University of Virginia:

Estimated Enrollment:   108
Study Start Date:   August 2004
Estimated Study Completion Date:   May 2006

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, in children with persistent diarrhea or malnutrition; on diarrhea frequency and duration, weight gain, protein loss, intestinal inflammation, and lactoferrin excretion.

  Eligibility
Ages Eligible for Study:   3 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. 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.
  2. Be an inpatient and willing to stay for 7 nights at HIAS.
  3. Child´s parent or guardian must sign informed consent..

Exclusion Criteria:

  1. Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
  2. 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.)
  3. Children with suspected other illnesses as indicated by fever >102º F at time of screening off antipyretics
  4. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
  5. 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133562

Sponsors and Collaborators

Investigators
Principal Investigator:     Richard L Guerrant, MD     University of Virginia    
  More Information


Responsible Party:   University of Virginia ( Richard Guerrant )
Study ID Numbers:   11375
First Received:   August 19, 2005
Last Updated:   October 27, 2008
ClinicalTrials.gov Identifier:   NCT00133562
Health Authority:   United States: Federal Government

Keywords provided by University of Virginia:
Malnutrition, pediatric, Brazil, alanyl-glutamine  

Study placed in the following topic categories:
Signs and Symptoms
Diarrhea
Malnutrition
Signs and Symptoms, Digestive
Glycine
Nutrition Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Glycine Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2008




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