Zinc and Biobehavioral Development in Early Childhood

Not Applicable

Completed

• Conditions: Child Development
• Interventions: Dietary Supplement: iron + copper; Dietary Supplement: zinc

• Registration Number: NCT00589264
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Primary Completion: 2008-05
• Study Completion: 2009-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Born at term of non-low birth weight
• Free of major malformations, genetic abnormalities or health problems associated with developmental delays
• Planning to remain in study area for one year
• In good general health

Exclusion Criteria

• Low birth weight
• Non-term delivery
• Vision or hearing problems
• Anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	iron + copper	iron + copper only
1	zinc	iron + copper + zinc

Primary Outcome Measures

Name	Time	Method
cognitive development(visual attention, executive processing, vigilance)	6, 9, 12, and 18 months

Trial Locations

Locations (1)

Instituto de Investigacion Nutricional; 🇵🇪 Lima, Peru