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

Primary Purpose

Diarrhea, Malnutrition

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
alanyl-glutamine
glycine
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea, Malnutrition focused on measuring Diarrhea, Malnutrition, Brazil

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2006
    Last Updated
    October 27, 2008
    Sponsor
    University of Virginia
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338221
    Brief Title
    Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
    Official Title
    Prospective Double Blinded Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2008
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Virginia
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diarrhea, Malnutrition
    Keywords
    Diarrhea, Malnutrition, Brazil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    108 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    alanyl-glutamine
    Intervention Type
    Drug
    Intervention Name(s)
    glycine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard L Guerrrant, MD
    Organizational Affiliation
    University of Virginia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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