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

Iron Deficiency Clinical Trial

— IDBB  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00515918
• Other study ID #: C030104-30671773
• Status: Not yet recruiting
• Phase: N/A
• First received: August 13, 2007
• Last updated: August 13, 2007
• Start date: September 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2007
• Source: Zhejiang University
• Contact: Jie Shao, M.D
• Phone: +86-571-87061007
• Email: shaojie[@]zju.edu.cn
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: September 2010
• Gender: Both
• Age group: N/A to 36 Months

Eligibility

Inclusion Criteria:

• Full- term infants

Exclusion Criteria:

• Prematures,

• Perinatal high risk infants(asphyxia,infection etc.),

• Maternal alcohol,

• Smoking,

• Drug abuse,

• Inherited diseases

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• iron

Locations

Country	Name	City	State
China	Children's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China,