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

NCT ID: NCT00133562

Last Updated: 2008-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Diarrhea, Malnutrition Other Nutritional Deficiencies

Keywords

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Malnutrition, pediatric, Brazil, alanyl-glutamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Alanyl-glutamine

Intervention Type DRUG

Glycine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia

Principal Investigators

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Richard L Guerrant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Countries

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Brazil United States

Other Identifiers

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11375

Identifier Type: -

Identifier Source: org_study_id