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Zinc and Biobehavioral Development in Early Childhood

Johns Hopkins Bloomberg School of Public Health logo

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Conditions

Child Development

Treatments

Dietary Supplement: zinc
Dietary Supplement: iron + copper

Study type

Interventional

Funder types

Other

Identifiers

NCT00589264
5R01HD045430 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

251 patients

Sex

All

Ages

6 to 18 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

251 participants in 2 patient groups

1
Experimental group
Description:
iron + copper + zinc
Treatment:
Dietary Supplement: zinc
2
Active Comparator group
Description:
iron + copper only
Treatment:
Dietary Supplement: iron + copper

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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