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| Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Instituto de Investigacion Nutricional University of Kansas University of Chicago |
|---|---|
| Information provided by: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00589264 |
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: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Official Title: | Zinc and Biobehavioral Development in Early Childhood |
| 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 |
|---|---|
|
1: Experimental
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
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|
2: Active Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Peru | |
| Instituto de Investigacion Nutricional | |
| Lima, Peru | |
| Principal Investigator: | Laura E Caulfield, PhD | Johns Hopkins Bloomberg SPH |
More Information
| Responsible Party: | The Johns Hopkins Bloomberg School of Public Health ( Laura Caulfield ) |
| Study ID Numbers: | 5 RO1 HD045430, 5 RO1 HD045430 |
| Study First Received: | December 24, 2007 |
| Last Updated: | January 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00589264 History of Changes |
| Health Authority: | Peru: Ministry of Health |
|
zinc iron child development visual attention Peru |
|
Zinc Trace Elements Micronutrients Copper Iron |
|
Growth Substances Physiological Effects of Drugs Zinc |
Trace Elements Micronutrients Pharmacologic Actions |
