Overview

Long-term Impact and Intervention for Diarrhea in Brazil

Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Virginia
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Glycine
Retinol palmitate
Vitamin A
Vitamins
Criteria
Inclusion Criteria:

Children ages 2 months to 8 years with height for age Z-score (HAZ) less than the median
for the Parque Universitario community. Be a resident in Brazilian flavela. Child's parent
or guardian must sign informed consent.

Exclusion Criteria:

Children exclusively breast-fed. Children who participated in the "hospital study" or any
other study with in the past two years. Children with fever > 102 F at time of screening.
Children with systemic disease at the time of screening including but not limited to:
shock, meningitis, sepsis, pneumonia, tuberculosis, varicella. Children on antibiotics
during screening. Children with siblings from the same household enrolled in this study.