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

Primary Purpose

Diarrhea, Malnutrition, Other Nutritional Deficiencies

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Withdrawn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 Malnutrition, pediatric, Brazil, alanyl-glutamine

Eligibility Criteria

3 Months - 3 Years (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 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 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 >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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2005
    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
    NCT00133562
    Brief Title
    HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition
    Official Title
    Prospective Double Blind Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Hospitalized 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
    May 2006 (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 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, in children with persistent diarrhea or malnutrition; on diarrhea frequency and duration, weight gain, protein loss, intestinal inflammation, and lactoferrin excretion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diarrhea, Malnutrition, Other Nutritional Deficiencies
    Keywords
    Malnutrition, pediatric, Brazil, alanyl-glutamine

    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
    3 Years
    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 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 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 >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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard L Guerrant, MD
    Organizational Affiliation
    University of Virginia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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