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

NCT00133562 | Withdrawn Phase 3

• 1 other identifier: 11375
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diarrhea, Malnutrition; Other Nutritional Deficiencies

Keywords

Malnutrition, pediatric, Brazil, alanyl-glutamine

Interventions

Alanyl-glutamine DRUG

Glycine DRUG

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Diarrhea; Malnutrition

Interventions

alanylglutamine; Glycine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Richard L Guerrant, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: August 1, 2004
• Study Completion: May 1, 2006
• Last Updated: October 28, 2008

Record last verified: 2008-10