drugset / Trial / NCT00133406
Long-term Impact and Intervention for Diarrhea in Brazil
Phase 3
Unknown
321 enrolled
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedFactorialQuadruple-blindTreatment
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.
Timeline
- Start
- 2006-06
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- 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.
- Lima 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.
- Mitter 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.
- Lima 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glutamine | Other / unclassified | 0.8 g/kg | Oral |
| Subject | Vitamin A | Unknown | 100000 iu | Oral |
| Subject | Vitamin A | Unknown | 200000 iu | Oral |
| Subject | Zinc Sulfate | Unknown | 40 mg | Oral |