- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515918
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
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 Contact
- Name: Jie Shao, M.D
- Phone Number: 2428 +86-571-87061007
- Email: shaojie@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Children's Hospital, Zhejiang University School of Medicine
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Contact:
- Zhengyan Zhao, M.D
- Phone Number: +86-571-87061007
- Email: zhaozy@zju.edu.cn
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Principal Investigator:
- Zhengyan Zhao, M.D
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Sub-Investigator:
- Jie Shao, M.D
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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
|
|
2
Iron sufficient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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The University of Texas Health Science Center,...CompletedIron Deficiency AnemiaUnited States
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Xinhua Hospital, Shanghai Jiao Tong University...Completed
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Mitsubishi Tanabe Pharma CorporationCompleted
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Société des Produits Nestlé (SPN)Completed