The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants (IDBB)
Recruitment status was Not yet recruiting
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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 Time Perspective: Prospective |
| 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 |
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| Contact: Jie Shao, M.D | +86-571-87061007 ext 2428 | shaojie@zju.edu.cn |
| 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 | |
| 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 May 23, 2013