Long-term Impact and Intervention for Diarrhea in Brazil
2 other identifiers
interventional
321
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 8, 2011
March 1, 2011
5.5 years
August 19, 2005
March 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
L:M ratio at 1.5 months
1.5 months
Secondary Outcomes (3)
L:M ratio at 4 & 12 months
4 and 12 months
HAZ
1.5, 4, 8, 12, 24, and 36 months
Diarrhea burden
4, 8, 12, 24, and 36 months
Study Arms (6)
a
EXPERIMENTALoral glutamine with juice for 10 days
b
EXPERIMENTALPO vit A q 4 mo for 1 year plus zinc placebo
c
ACTIVE COMPARATORZinc 40 mg twice weekly Plus Vitamin A Placebo for one year
d
PLACEBO COMPARATORoral glycine with juice daily for 10 days
e
PLACEBO COMPARATORVitamin A Placebo plus Zinc Placebo for one year
f
EXPERIMENTALVitamin A q 4 months and PO Zinc for 1 year
Interventions
100,000 IU for children under 12 months of age (or placebo) and PO 200,000 IU for children at least 12 months of age (or placebo), both q months for 1 year at 0, 4 and 8 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Ceará
Fortaleza, 60436160, Brazil
Related Publications (4)
Lima AA, Anstead GM, Zhang Q, Figueiredo IL, Soares AM, Mota RM, Lima NL, Guerrant RL, Oria RB. Effects of glutamine alone or in combination with zinc and vitamin A on growth, intestinal barrier function, stress and satiety-related hormones in Brazilian shantytown children. Clinics (Sao Paulo). 2014;69(4):225-33. doi: 10.6061/clinics/2014(04)02.
PMID: 24714829DERIVEDLima AA, Kvalsund MP, Souza PP, Figueiredo IL, Soares AM, Mota RM, Lima NL, Pinkerton RC, Patrick PP, Guerrant RL, Oria RB. Zinc, vitamin A, and glutamine supplementation in Brazilian shantytown children at risk for diarrhea results in sex-specific improvements in verbal learning. Clinics (Sao Paulo). 2013;68(3):351-8. doi: 10.6061/clinics/2013(03)oa11.
PMID: 23644855DERIVEDMitter SS, Oria RB, Kvalsund MP, Pamplona P, Joventino ES, Mota RM, Goncalves DC, Patrick PD, Guerrant RL, Lima AA. Apolipoprotein E4 influences growth and cognitive responses to micronutrient supplementation in shantytown children from northeast Brazil. Clinics (Sao Paulo). 2012;67(1):11-8. doi: 10.6061/clinics/2012(01)03.
PMID: 22249475DERIVEDLima AA, Soares AM, Lima NL, Mota RM, Maciel BL, Kvalsund MP, Barrett LJ, Fitzgerald RP, Blaner WS, Guerrant RL. Effects of vitamin A supplementation on intestinal barrier function, growth, total parasitic, and specific Giardia spp infections in Brazilian children: a prospective randomized, double-blind, placebo-controlled trial. J Pediatr Gastroenterol Nutr. 2010 Mar;50(3):309-15. doi: 10.1097/MPG.0b013e3181a96489.
PMID: 20038852DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Guerrant, MD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 23, 2005
Study Start
June 1, 2006
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 8, 2011
Record last verified: 2011-03