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

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ClinicalTrials.gov Identifier: NCT00133562
Recruitment Status : Withdrawn
First Posted : August 23, 2005
Last Update Posted : October 28, 2008
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Virginia

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.

Condition or disease Intervention/treatment Phase
Diarrhea, Malnutrition Other Nutritional Deficiencies Drug: Alanyl-glutamine Drug: Glycine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective Double Blind Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Hospitalized Children With Persistent Diarrhea or Malnutrition.
Study Start Date : August 2004
Study Completion Date : May 2006

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Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133562


Sponsors and Collaborators
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Richard L Guerrant, MD University of Virginia

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Responsible Party: Richard Guerrant, University of Virginia
ClinicalTrials.gov Identifier: NCT00133562    
Other Study ID Numbers: 11375
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: October 28, 2008
Last Verified: October 2008
Keywords provided by University of Virginia:
Malnutrition, pediatric, Brazil, alanyl-glutamine
Additional relevant MeSH terms:
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Malnutrition
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrition Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs