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OpenTrials
Completed

NCT Number: NCT00589264

Zinc and Biobehavioral Development in Early Childhood

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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Key information

Conditions

Child Development

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Investigacion Nutricional

Lima, Peru

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc

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

iron + copper

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

Primary outcomes

  1. cognitive development(visual attention, executive processing, vigilance)

    Time frame: 6, 9, 12, and 18 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Instituto de Investigacion Nutricional, Peru
  • University of Chicago
  • University of Kansas

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Jan 9, 2008
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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