The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants

NCT ID: NCT00515918

Last Updated: 2007-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this project to examine brain functions and behavior related to ID including sensory ,motor, cognitive and social /emotional functioning, and address unanswered questions about brain and behavior impacts of different timing of ID(pre- and /or postnatal ID) in infants.

Detailed Description

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Iron deficiency (ID) is the most common single nutrient disorder in the world. Pregnant women and children before pre-school age are at highest risk. Data from animal models provide evidence that early ID affected developing brain in specific regions and functions by varies processes include myelination, dopamine neurotransmitter system, and neurometabolism. These impacts appeared differential at different time of brain development and different brain regions, depending on the timing of ID. The reversibility of these effects also appeared to depend on the timing of ID. This project uses innovative neuropsychologic/ neurophysiologic and behavioral techniques, such as event-related potentials(ERP), ABR and VEP, to study brain functions and behavior related to ID including sensory ,motor, cognitive and social /emotional functioning, and address unanswered questions about brain and behavior impacts of different timing of ID(pre- and /or postnatal ID) in the human infants. This research has the potential to understand reversibility of effects depending on timing of ID and treatment as well as basic understanding of mechanism of impact of ID in human developing brain. It may also have important implications with regard to policy of interventions for different timing of ID, and improve children early development and the quality of population.

Conditions

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Iron Deficiency

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Iron deficient

iron

Intervention Type DIETARY_SUPPLEMENT

2

Iron sufficient

No interventions assigned to this group

Interventions

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iron

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Full- term infants

Exclusion Criteria

* Prematures,
* Perinatal high risk infants(asphyxia,infection etc.),
* Maternal alcohol,
* Smoking,
* Drug abuse,
* Inherited diseases
Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Principal Investigators

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Zhengyan Zhao, M.D

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University School of Medicine, Children's Hosp

Locations

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Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Jie Shao, M.D

Role: CONTACT

+86-571-87061007 ext. 2428

Facility Contacts

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Zhengyan Zhao, M.D

Role: primary

+86-571-87061007

Other Identifiers

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C030104-30671773

Identifier Type: -

Identifier Source: org_study_id