Zinc and Biobehavioral Development in Early Childhood | NCT00589264

Studies
Zinc and Biobehavioral Development in Early Childhood

NCT00589264

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Sep 9, 2014Estimated

Enrollment

251Actual

Phase

Not Applicable

Conditions

Child Development

Interventions

zinc
iron + copper

Countries

Peru

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01HD045430	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

May 2008Actual

Completion Date

Jun 2009Actual

First Submitted Date

Dec 24, 2007

First Submission Date that Met QC Criteria

Jan 8, 2008

First Posted Date

Jan 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2014

Last Update Posted Date

Sep 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laura Caulfield, Professor, Johns Hopkins Bloomberg School of Public HealthPrincipal Investigator

Lead Sponsor

Johns Hopkins Bloomberg School of Public HealthOTHER

Collaborators

Name	Class
Instituto de Investigacion Nutricional, Peru	OTHER
University of Kansas	OTHER
University of Chicago	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

251Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	iron + copper + zinc	Dietary Supplement: zinc
2	Active Comparator	iron + copper only	Dietary Supplement: iron + copper

Interventions

Name	Type	Description	Arm Group Labels	Other Names
zinc	Dietary Supplement	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	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cognitive development(visual attention, executive processing, vigilance)		6, 9, 12, and 18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura E Caulfield, PhD	Johns Hopkins Bloomberg SPH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Investigacion Nutricional		Lima			Peru

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36994923	Derived	Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
24850625	Derived	Colombo J, Zavaleta N, Kannass KN, Lazarte F, Albornoz C, Kapa LL, Caulfield LE. Zinc supplementation sustained normative neurodevelopment in a randomized, controlled trial of Peruvian infants aged 6-18 months. J Nutr. 2014 Aug;144(8):1298-305. doi: 10.3945/jn.113.189365. Epub 2014 May 21.

ID	Term
D015032	Zinc
D007501	Iron
D003300	Copper

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements