Iron DeficiencyIDBBNCT00515918
The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants
An observational study of Iron Deficiency, run by Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- iron
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Sep 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- Child
Who may be able to join
- Full- term infants
Who cannot join
- Prematures,
- Perinatal high risk infants(asphyxia,infection etc.),
- Maternal alcohol,
- Smoking,
- Drug abuse,
- Inherited diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhengyan Zhao, M.D, +86-571-87061007, zhaozy@zju.edu.cn
Zhengyan Zhao, M.D
About this study
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.
Read the 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.
- Conditions
- Iron Deficiency
- Being tested
- iron
- Keywords
- Iron deficiency, brain, cognition, behavior
- Medical subject headings
- Iron Deficiencies, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ironDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Iron deficient Receives: Dietary Supplement: iron | |
| 2 | Iron sufficient |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startSep 2007
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Investigators
- Zhengyan Zhao, M.D, Principal investigator, Zhejiang University School of Medicine, Children's Hosp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515918
- Sponsor's protocol ID
- C030104-30671773
- Acronym
- IDBB
- Status last verified
- Aug 2007
- First submitted
- 13 Aug 2007
- Last updated
- 14 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants
- ClinicalTrials.gov ID
- NCT00515918
- Acronym / sponsor ID
- IDBB / C030104-30671773
- Conditions
- Iron Deficiency
- Keywords
- Iron deficiency, brain, cognition, behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Sep 2010 (estimated)
- First posted
- 14 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Defined population
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Dietary Supplement: ironIron deficient |
| 2 | – | –Iron sufficient |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Full- term infants
Key exclusion criteria (6 listed)
- Prematures,
- Perinatal high risk infants(asphyxia,infection etc.),
- Maternal alcohol,
- Smoking,
- Drug abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron | Dietary supplement | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengyan Zhao, M.D principal investigator
Zhejiang University School of Medicine, Children's Hosp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Shao, M.D (+86-571-87061007 ext. 2428, shaojie@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2007; AzTrials last refreshed its copy on 6 Nov 2026.