Long-term Impact and Intervention for Diarrhea in Brazil
March 4, 2011 updated by: University of Virginia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Subjects will be enrolled into this prospective, randomized, placebo controlled study of the Long-term Impact and Intervention for Diarrhea in Brazil.
Children meeting the inclusion criteria will be prospectively, randomized to four arms: (1) placebo: placebo (2) Vitamin A: Zinc Placebo (3) Vitamin A Placebo:Zinc (4) Vitamin A:Zinc.
Intervention will last for one year with two additional years of follow up.
A nested study involving all patients will take place at week four.
At week four there will be a second randomization to either oral glutamine or glycine (placebo) for an additional ten days.
The primary endpoint of the nested study will be the L:M ratio at 6 weeks.
The master randomization list will be broken, only by combined approval of the Principal Investigators, at the end of the study or in the unexpected event of a child needing removal from the study (for that case only).
All randomized subjects will be visited in their home two times per week for assessment of intercurrent diarrhea.
At 1, 4, 8, 12, 24 and 36 months patients will have a nutritional status/anthropometry and diarrheal illness rate assessment.
At 0, 1, 1.5, and 4 months all randomized subjects will have a Lactulose:Mannose Ratio (L:M) performed.
A blood Zinc and Vitamin A level will be drawn at 0 and 4 months.
Also a stool microbiology, lactoferrin and protein loss assessment will be completed at 1 month.
All randomized subjects who complete the protocol should have assessments as outlined above at 36 weeks.
The primary effect of interest is the difference in mean HAZ changes between children receiving Zinc plus Vitamin A compared to children receiving no Vitamin A or Zinc, averaging the difference in children receiving glutamine and children not receiving glutamine.
Study Type
Interventional
Enrollment (Anticipated)
321
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fortaleza, Brazil, 60436160
- Recruiting
- Federal University of Ceará
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: a
oral glutamine with juice for 10 days
|
0.8gm/kg, ie up to a total daily dose of 16.2gm/day,with juice daily for 10 days
|
|
Experimental: b
PO vit A q 4 mo for 1 year plus zinc placebo
|
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.
40 mg twice weekly for 12 months
|
|
Active Comparator: c
Zinc 40 mg twice weekly Plus Vitamin A Placebo for one year
|
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.
40 mg twice weekly for 12 months
|
|
Placebo Comparator: d
oral glycine with juice daily for 10 days
|
0.4gm/kg; ie up to 8.3gm/d, with juice daily for 10 days
|
|
Placebo Comparator: e
Vitamin A Placebo plus Zinc Placebo for one year
|
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.
40 mg twice weekly for 12 months
|
|
Experimental: f
Vitamin A q 4 months and PO Zinc for 1 year
|
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.
40 mg twice weekly for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
L:M ratio at 1.5 months
Time Frame: 1.5 months
|
1.5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
L:M ratio at 4 & 12 months
Time Frame: 4 and 12 months
|
4 and 12 months
|
|
HAZ
Time Frame: 1.5, 4, 8, 12, 24, and 36 months
|
1.5, 4, 8, 12, 24, and 36 months
|
|
Diarrhea burden
Time Frame: 4, 8, 12, 24, and 36 months
|
4, 8, 12, 24, and 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard L Guerrant, MD, University of Virginia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
August 19, 2005
First Submitted That Met QC Criteria
August 19, 2005
First Posted (Estimate)
August 23, 2005
Study Record Updates
Last Update Posted (Estimate)
March 8, 2011
Last Update Submitted That Met QC Criteria
March 4, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12475
- 05-0071 (NIAID)
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