Status:
UNKNOWN
Long-term Impact and Intervention for Diarrhea in Brazil
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Diarrheal Disorder
Eligibility:
All Genders
2-8 years
Phase:
PHASE3
Brief 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 n...
Detailed Description
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. Subj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00133406
Start Date
June 1 2006
End Date
December 1 2011
Last Update
March 8 2011
Active Locations (1)
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1
Federal University of Ceará
Fortaleza, Brazil, 60436160