Full Text View
Tabular View
No Study Results Posted
Related Studies
Micronutrient Intervention in Brazil
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), May 2008
First Received: January 11, 2007   Last Updated: May 15, 2008   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00421382
  Purpose

The purpose of this study is to investigate the effects of micronutrients (zinc, arginine) on the health of children in Brazil who have had episodes of chronic diarrhea and are malnourished. Approximately 270-321 healthy but malnourished children 2-36 months old will be enrolled. Children will be given placebo (an inactive treatment) or zinc with or without arginine. Daily visits are required for a 12-week period followed by in-home visits twice weekly during weeks 12-64 of the study. Expected participation is 3-4.5 years. Information about illness, diarrhea, nutrition, measurements/weight and fecal samples will be collected.


Condition Intervention Phase
Diarrheal Diseases
Other Nutritional Deficiencies
Drug: Placebo
Drug: arginine
Drug: glycine
Drug: zinc
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title: Long Term Impact and Intervention With Micronutrients in Brazil Parque Universitário, Community-Based Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 321
Study Start Date: January 2008
Estimated Study Completion Date: July 2012
Detailed Description:

Arginine and zinc deficiencies, under stress of intestinal damage by infectious agents, may each have severely limiting effects on critical intestinal barrier and absorptive function. As arginine and zinc deficiencies, and multiple enteric infections associated with malnutrition with or without persistent diarrhea, are common in children living in impoverished tropical areas, micronutrient replacement with arginine and zinc may be necessary for the host to fully respond to oral rehydration and nutrition therapy (ORNT). The primary objective of the study is to determine the effect (improvement in HAZ, which is the height-for-age Z score) of supplementation of arginine plus zinc versus placebo (glycine or zinc vehicle) on 12-month linear growth in children living in a Brazilian shantytown (favela). The first of the 2 secondary study objectives is to determine the effect of supplementation of arginine plus zinc versus placebo on the following: number of episodes of diarrhea and days of diarrhea over 12 months; physical development as measured by growth at 6, 24 and 36 months post-treatment (HAZ, weight-for-age Z-score [WAZ], and weight-for-height Z-score [WHZ]); intestinal integrity as measured by the lactulose:mannitol (L:M) ratio at 0, 6 and 12 weeks and inflammation as measured by lactoferrin assay at 0 and 12 weeks; cognitive function testing conducted one time in years 3 to 4.5 of the study when the children are at least 4 years old; and stool pathogens at Weeks 0 and 12. The second of the 2 secondary objectives is to determine the effect of supplementation of zinc versus placebo on: physical development as measured by growth at 12 months post treatment (HAZ, WAZ, and WHZ); and intestinal integrity as measured by L:M ratio at 6 and 12 weeks and inflammation as measured by lactoferrin assay at 0 and 12 weeks. This is a single-center, community-based, placebo-controlled, double-blind phase 3 study of 2 to 36 month old healthy, but malnourished HAZ less than -0.35 (height-for-age Z-score less than median of this population, based on previous ICIDR [International Collaborations in Infectious Disease Research] HAZ values in 2-36 month old children) children. There will be 3 study arms. Each arm will consist of 90 (107) subjects for a total of 270 (321) subjects. The children will be randomly assigned to 3 permuted blocks to assess the effects of zinc, with or without arginine, given under direct observation for 12 weeks on nutritional status (primarily HAZ after 12 months). In addition to the daily visits for the 12-week treatment period, for 1 year all subjects will be visited in their home 2 times a week for assessment of intercurrent diarrhea. The expected duration of subject participation is 3 to 4.5 years. All subjects are expected to be enrolled over the first 1.5-2 years allowing a 1-4 year follow up. The primary endpoint is HAZ at 12 months post treatment, based on past published and preliminary data in the background of the proposal. Long term follow-up is key to detecting effects on cognitive development and duration of improvements in nutritional status (as previously reported that long-term effects are associated with early childhood diarrhea and malnutrition.

  Eligibility

Ages Eligible for Study:   2 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 2 to 36 months with malnutrition HAZ less than -0.35 (Height-for-age Z-score less than the median for the Parque Universitário community);
  • Resident in Parque Universitário;
  • Child's parent(s) or guardian(s) must provide informed consent.

Exclusion Criteria:

  • Children who are exclusively breast fed;
  • Children who participated in any other study within the past 2 years;
  • Children with fever 39 degrees C at time of screening;
  • Children who are on antibiotics during screening;
  • Children with systemic disease or serious medical condition or retardation at the time of screening, including but not limited to: shock, meningitis, sepsis, pneumonia, tuberculosis, varicella;
  • Children who are severely malnourished (HAZ less than -3);
  • Child who cannot retain or absorb supplements (due to vomiting or diarrhea) at the time of screening;
  • Children with siblings from the same household enrolled in this study (although siblings of children in previous studies may enroll).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421382

Contacts
Contact: Richard Guerrant (434) 924-5242

Locations
Brazil
Federal University of Ceará Recruiting
Fortaleza, Brazil, 60436160
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 05-0071
Study First Received: January 11, 2007
Last Updated: May 15, 2008
ClinicalTrials.gov Identifier: NCT00421382     History of Changes
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
micronutrients, Brazil, malnutrition, children, infants

Study placed in the following topic categories:
Malnutrition
Arginine
Glycine
Zinc
Nutrition Disorders
Trace Elements
Micronutrients

Additional relevant MeSH terms:
Malnutrition
Growth Substances
Physiological Effects of Drugs
Nutrition Disorders
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009