Clinical Trials Directory

Trials / Completed

CompletedNCT00589264

Zinc and Biobehavioral Development in Early Childhood

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
251 (actual)
Sponsor
Johns Hopkins Bloomberg School of Public Health · Academic / Other
Sex
All
Age
6 Months – 18 Months
Healthy volunteers
Accepted

Summary

Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTzinc10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age
DIETARY_SUPPLEMENTiron + copper10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age

Timeline

Start date
2004-07-01
Primary completion
2008-05-01
Completion
2009-06-01
First posted
2008-01-09
Last updated
2014-09-09

Locations

1 site across 1 country: Peru

Source: ClinicalTrials.gov record NCT00589264. Inclusion in this directory is not an endorsement.