Long-term Impact and Intervention for Diarrhea in Brazil
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ClinicalTrials.gov Identifier: NCT00133406 |
Recruitment Status : Unknown
Verified March 2011 by University of Virginia.
Recruitment status was: Recruiting
First Posted : August 23, 2005
Last Update Posted : March 8, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diarrheal Disorder | Drug: Glutamine Drug: Vitamin A Drug: glycine Drug: zinc | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 321 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Long-term Impact and Intervention for Diarrhea in Brazil |
Study Start Date : | June 2006 |
Estimated Primary Completion Date : | December 2011 |
Estimated Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: a
oral glutamine with juice for 10 days
|
Drug: Glutamine
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
|
Drug: Vitamin A
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. Drug: zinc 40 mg twice weekly for 12 months |
Active Comparator: c
Zinc 40 mg twice weekly Plus Vitamin A Placebo for one year
|
Drug: Vitamin A
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. Drug: zinc 40 mg twice weekly for 12 months |
Placebo Comparator: d
oral glycine with juice daily for 10 days
|
Drug: glycine
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
|
Drug: Vitamin A
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. Drug: zinc 40 mg twice weekly for 12 months |
Experimental: f
Vitamin A q 4 months and PO Zinc for 1 year
|
Drug: Vitamin A
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. Drug: zinc 40 mg twice weekly for 12 months |
- L:M ratio at 1.5 months [ Time Frame: 1.5 months ]
- L:M ratio at 4 & 12 months [ Time Frame: 4 and 12 months ]
- HAZ [ Time Frame: 1.5, 4, 8, 12, 24, and 36 months ]
- Diarrhea burden [ Time Frame: 4, 8, 12, 24, and 36 months ]

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Ages Eligible for Study: | 2 Months to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133406
Contact: Richard Guerrant | (434) 924-5242 |
Brazil | |
Federal University of Ceará | Recruiting |
Fortaleza, Brazil, 60436160 |
Principal Investigator: | Richard L Guerrant, MD | University of Virginia |
Responsible Party: | Richard Guerrant, University of VA |
ClinicalTrials.gov Identifier: | NCT00133406 |
Obsolete Identifiers: | NCT00421382 |
Other Study ID Numbers: |
12475 05-0071 ( Other Identifier: NIAID ) |
First Posted: | August 23, 2005 Key Record Dates |
Last Update Posted: | March 8, 2011 |
Last Verified: | March 2011 |
Brazil, Child Nutrition Disorders, Deficiency Diseases |
Diarrhea Signs and Symptoms, Digestive Vitamin A Glycine Vitamins |
Micronutrients Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Glycine Agents Neurotransmitter Agents |