The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants (IDBB)
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2007 | ||||
| Last Updated Date | August 13, 2007 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Iron Deficiency | ||||
| Intervention ICMJE | Dietary Supplement: iron | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Estimated Completion Date | September 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 36 Months | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00515918 | ||||
| Other Study ID Numbers ICMJE | C030104-30671773 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Zhejiang University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Zhejiang University | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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