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Zinc and Biobehavioral Development in Early Childhood

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Instituto de Investigacion Nutricional
University of Kansas
University of Chicago
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00589264
First received: December 24, 2007
Last updated: January 8, 2008
Last verified: December 2007
History of Changes

December 24, 2007
January 8, 2008
July 2004
May 2008   (final data collection date for primary outcome measure)
cognitive development(visual attention, executive processing, vigilance) [ Time Frame: 6, 9, 12, and 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589264 on ClinicalTrials.gov Archive Site
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Zinc and Biobehavioral Development in Early Childhood
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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Child Development
  • 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
  • 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
  • Experimental: 1
    iron + copper + zinc
    Intervention: Dietary Supplement: zinc
  • Active Comparator: 2
    iron + copper only
    Intervention: Dietary Supplement: iron + copper
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
251
June 2009
May 2008   (final data collection date for primary outcome measure)

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
Both
6 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00589264
5 RO1 HD045430, 5 RO1 HD045430
No
Laura Caulfield, The Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • Instituto de Investigacion Nutricional
  • University of Kansas
  • University of Chicago
Principal Investigator: Laura E Caulfield, PhD Johns Hopkins Bloomberg SPH
Johns Hopkins Bloomberg School of Public Health
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP