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NCT00133406 Clinical Trial

Long-term Impact and Intervention for Diarrhea in Brazil

Diarrheal Disorder Clinical Trial

Official title:
Long-term Impact and Intervention for Diarrhea in Brazil

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00133406
Other study ID # 12475
Secondary ID 05-0071
Status Recruiting
Phase Phase 3
First received August 19, 2005
Last updated March 4, 2011
Start date June 2006
Est. completion date December 2011

Study information
Verified date March 2011
Source University of Virginia
Contact Richard Guerrant
Phone (434) 924-5242
Is FDA regulated No
Health authority Brazil: Ministry of HealthUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Other known NCT identifiers
  • NCT00421382

Recruitment information / eligibility
Status Recruiting
Enrollment 321
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 8 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Glutamine
0.8gm/kg, ie up to a total daily dose of 16.2gm/day,with juice daily for 10 days
• 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.
• glycine
0.4gm/kg; ie up to 8.3gm/d, with juice daily for 10 days
• zinc
40 mg twice weekly for 12 months

Locations
Country Name City State
Brazil Federal University of Ceará Fortaleza

Sponsors (2)
Lead Sponsor Collaborator
University of Virginia National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary L:M ratio at 1.5 months 1.5 months No
Secondary L:M ratio at 4 & 12 months 4 and 12 months No
Secondary HAZ 1.5, 4, 8, 12, 24, and 36 months No
Secondary Diarrhea burden 4, 8, 12, 24, and 36 months No