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
  Purpose

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 Intervention
Child Development
Dietary Supplement: zinc
Dietary Supplement: iron + copper

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Zinc and Biobehavioral Development in Early Childhood

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • cognitive development(visual attention, executive processing, vigilance) [ Time Frame: 6, 9, 12, and 18 months ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: July 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589264

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

No publications provided

Responsible Party: Laura Caulfield, The Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00589264     History of Changes
Other Study ID Numbers: 5 RO1 HD045430, 5 RO1 HD045430
Study First Received: December 24, 2007
Last Updated: January 8, 2008
Health Authority: Peru: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014