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

Diarrhea, Malnutrition Clinical Trial

Official title:

Prospective Double Blind Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Hospitalized Children With Persistent Diarrhea or Malnutrition.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00133562
• Other study ID #: 11375
• Status: Withdrawn
• Phase: Phase 3
• First received: August 19, 2005
• Last updated: October 27, 2008
• Start date: August 2004
• Est. completion date: May 2006

Study information

• Verified date: October 2008
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 108
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 3 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea, Malnutrition
• Malnutrition
• Other Nutritional Deficiencies

Intervention

Drug:
• Alanyl-glutamine

• Glycine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Allergy and Infectious Diseases (NIAID)