Long-term Impact and Intervention for Diarrhea in Brazil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00133406
First received: August 19, 2005
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Diarrheal Disorder
Drug: Glutamine
Drug: Vitamin A
Drug: glycine
Drug: zinc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Impact and Intervention for Diarrhea in Brazil

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • L:M ratio at 1.5 months [ Time Frame: 1.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • L:M ratio at 4 & 12 months [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
  • HAZ [ Time Frame: 1.5, 4, 8, 12, 24, and 36 months ] [ Designated as safety issue: No ]
  • Diarrhea burden [ Time Frame: 4, 8, 12, 24, and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 321
Study Start Date: June 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133406

Contacts
Contact: Richard Guerrant (434) 924-5242

Locations
Brazil
Federal University of Ceará Recruiting
Fortaleza, Brazil, 60436160
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Richard L Guerrant, MD University of Virginia
  More Information

No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Guerrant, University of VA
ClinicalTrials.gov Identifier: NCT00133406     History of Changes
Obsolete Identifiers: NCT00421382
Other Study ID Numbers: 12475, 05-0071
Study First Received: August 19, 2005
Last Updated: March 4, 2011
Health Authority: Brazil: Ministry of Health
United States: Institutional Review Board

Keywords provided by University of Virginia:
Brazil, Child Nutrition Disorders, Deficiency Diseases

Additional relevant MeSH terms:
Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014