Zinc and Biobehavioral Development in Early Childhood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

iron + copper + zinc

Group Type EXPERIMENTAL

zinc

Intervention Type DIETARY_SUPPLEMENT

10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age

2

iron + copper only

Group Type ACTIVE_COMPARATOR

iron + copper

Intervention Type DIETARY_SUPPLEMENT

10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age

Interventions

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zinc

10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age

Intervention Type DIETARY_SUPPLEMENT

iron + copper

10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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