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

August 13, 2007 updated by: Zhejiang University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Children's Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full- term infants

Exclusion Criteria:

  • Prematures,
  • Perinatal high risk infants(asphyxia,infection etc.),
  • Maternal alcohol,
  • Smoking,
  • Drug abuse,
  • Inherited diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Iron deficient
Dietary supplement: iron
2
Iron sufficient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Zhengyan Zhao, M.D, Zhejiang University School of Medicine, Children's Hosp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 14, 2007

Study Record Updates

Last Update Posted (Estimate)

August 14, 2007

Last Update Submitted That Met QC Criteria

August 13, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C030104-30671773

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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