Zinc and Biobehavioral Development in Early Childhood

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00589264

Enrollment

251

Registered

2008-01-09

Start date

2004-07-31

Completion date

2009-06-30

Last updated

2014-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

zinc, iron, child development, visual attention, Peru

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.

Interventions

DIETARY_SUPPLEMENTzinc

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

DIETARY_SUPPLEMENTiron + copper

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026