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Zinc and Biobehavioral Development in Early Childhood

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ClinicalTrials.gov Identifier: NCT00589264
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : September 9, 2014
Sponsor:
Collaborators:
Instituto de Investigacion Nutricional, Peru
University of Kansas
University of Chicago
Information provided by (Responsible Party):
Laura Caulfield, 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.

Condition or disease Intervention/treatment Phase
Child Development Dietary Supplement: zinc Dietary Supplement: iron + copper Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Zinc and Biobehavioral Development in Early Childhood
Study Start Date : July 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
iron + copper + zinc
Dietary Supplement: 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
Active Comparator: 2
iron + copper only
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



Primary Outcome Measures :
  1. cognitive development(visual attention, executive processing, vigilance) [ Time Frame: 6, 9, 12, and 18 months ]


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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589264


Locations
Peru
Instituto de Investigacion Nutricional
Lima, Peru
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Instituto de Investigacion Nutricional, Peru
University of Kansas
University of Chicago
Investigators
Principal Investigator: Laura E Caulfield, PhD Johns Hopkins Bloomberg SPH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laura Caulfield, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00589264     History of Changes
Other Study ID Numbers: 5R01HD045430 ( U.S. NIH Grant/Contract )
5R01HD045430 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Laura Caulfield, Johns Hopkins Bloomberg School of Public Health:
zinc
iron
child development
visual attention
Peru

Additional relevant MeSH terms:
Iron
Zinc
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs