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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Zhejiang University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00515918
First received: August 13, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Iron Deficiency
Dietary Supplement: iron

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Groups/Cohorts Assigned Interventions
Case: 1
Iron deficient
Dietary Supplement: iron
Control: 2
Iron sufficient

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.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Full- term infants

Exclusion Criteria:

  • Prematures,
  • Perinatal high risk infants(asphyxia,infection etc.),
  • Maternal alcohol,
  • Smoking,
  • Drug abuse,
  • Inherited diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515918

Contacts
Contact: Jie Shao, M.D +86-571-87061007 ext 2428 shaojie@zju.edu.cn

Locations
China, Zhejiang
Children's Hospital, Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Zhengyan Zhao, M.D    +86-571-87061007    zhaozy@zju.edu.cn   
Principal Investigator: Zhengyan Zhao, M.D         
Sub-Investigator: Jie Shao, M.D         
Sponsors and Collaborators
Zhejiang University
Investigators
Principal Investigator: Zhengyan Zhao, M.D Zhejiang University School of Medicine, Children's Hosp
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00515918     History of Changes
Other Study ID Numbers: C030104-30671773
Study First Received: August 13, 2007
Last Updated: August 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Zhejiang University:
Iron deficiency
brain
cognition
behavior

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014