Status:
COMPLETED
Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Universidade Federal do Ceara
Conditions:
Malnutrition
Environmental Enteropathy
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief Summary
Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries. These include intestinal inflammation, mucosal damage, and alte...
Eligibility Criteria
Inclusion
- Children who are undernourished or at risk of undernutrition, with anthropometric z-scores less than or equal to -1 for one of these parameters: height-for-age, weight-for-age, or weight-for-height.
- Children ages 2 months to 5 years old.
Exclusion
- Children who are exclusively breastfed.
- Have participated in another intervention study in the past two years.
- Fever greater than 38.8 ° C.
- Use of antibiotics.
- Systemic disease or other serious medical condition (including, but not limited to meningitis, pneumonia, tuberculosis, and chickenpox).
- Children who are unable to ingest, retain or absorb nutritional supplements.
- Children whose families plan to move from the study area within the next 6 months.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01832636
Start Date
October 1 2013
End Date
December 1 2015
Last Update
August 1 2016
Active Locations (1)
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1
Universidade Federal do Ceara
Fortaleza, Ceará, Brazil