Iron-Deficiency AnemiaNCT06662045
Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 to 24 Months
An observational study of Iron-Deficiency Anemia and Neurobehavioral Manifestations, run by Pingshan District Maternal & Child Healthcare Hospital of Shenzhen at 1 site in China.
Trial summary
The goal of this observational study is to explore the relationship between iron-deficiency anemia and neurobehavioral development in children aged 6-24 months. This study focuses on children who undergo health check-ups and blood tests at pediatric health clinics in Pingshan District, Shenzhen, China. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Iron-Deficiency Anemia, Neurobehavioral Manifestations, Growth Disorders
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months to 6 years
- All sexes
- Child
Study population: The study population will consist of children aged 6 to 24 months who attend children health care clinics for routine health check-ups and vaccinations. Participants will be recruited from both hospitals and community health centers within the designated region. The population will include children diagnosed with iron-deficiency anemia and non-anemic controls, providing a comparative sample. The study will aim to capture a diverse range of children from various socioeconomic backgrounds. Informed consent will be obtained from the parents or guardians before participation, and all children will meet the specified inclusion criteria for neurodevelopmental and physical growth evaluations.
Who may be able to join
- Children aged 6 to 24 months at the time of enrollment
- Diagnosed with iron-deficiency anemia (for the exposure group) or confirmed
- non-anemic status (for the control group) based on blood test results
- Resident in the study area for at least 6 months prior to enrollment
- Availability of parental or guardian consent to participate in the study and willingness to follow study protocols
- Completion of all baseline assessments, including neurodevelopmental and physical growth evaluations
Who cannot join
- Presence of congenital or chronic illnesses that could affect
- neurodevelopment, such as Down syndrome or cerebral palsy.
- History of severe infections or trauma within 3 months prior to enrollment that
- could influence neurodevelopmental outcomes
- Current use of medications or treatments that may interfere with iron metabolism (e.g., iron supplementation or blood transfusions in the last 6 months)
- Premature birth (before 37 weeks of gestation) or low birth weight (< 2,500 grams)
- Parental refusal to provide consent or non-compliance with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Healthcare
Shenzhen, China/Guangdong, 518118
Moujinsong Project Manager, +86 13632863500, moujs@foxmail.com
About this study
Official title: Study on the Association Between Iron Deficiency Anemia and Neurobehavioral Development and Cognitive Function in Children Aged 6 to 24 Months
The goal of this observational study is to explore the relationship between iron-deficiency anemia and neurobehavioral development in children aged 6-24 months. This study focuses on children who undergo health check-ups and blood tests at pediatric health clinics in Pingshan District, Shenzhen, China.
The main questions it aims to answer are:
Read more
How does iron-deficiency anemia affect children's neurobehavioral development, including motor skills, language ability, and social behavior? How does anemia influence growth and nutrition, such as weight, height, and body mass index (BMI) in children?
Participants will:
Undergo blood tests (including hemoglobin levels, serum ferritin, and serum iron) to assess anemia status.
Be assessed using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6" to measure motor, cognitive, language, and social development.
Provide general health information, such as birth history, feeding methods, and parental details, through interviews with trained surveyors.
Researchers will compare children with and without iron-deficiency anemia to determine differences in neurobehavioral outcomes and development levels. The findings aim to provide evidence for early interventions to prevent the negative impacts of anemia and support children's healthy development.
- Conditions
- Iron-Deficiency Anemia, Neurobehavioral Manifestations, Growth Disorders, Nutritional Status
- Medical subject headings
- Anemia, Iron-Deficiency, Neurobehavioral Manifestations, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Iron-Deficient Group | This group consists of children diagnosed with iron-deficiency anemia. | |
| Control Group (Non-Anemic) | This group consists of children without iron-deficiency anemia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral Development Score
This measure assesses neurobehavioral development, including motor skills, language, social behavior, and adaptability, using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6." The score is used to determine the developmental status of children in both the iron-deficiency and non-anemic groups.
Measured: Baseline assessment and follow-up at 6 months.
Hemoglobin (Hb)
To assess the severity of anemia.
Measured: Blood samples will be taken at baseline and follow-up at 3 months.
Serum Ferritin
To evaluate the iron stores in the body
Measured: Blood samples will be taken at baseline and follow-up at 3 months
Secondary outcomes (4)
Physical Growth (Height)
This measure evaluates the physical growth of children, specifically tracking changes in height. Growth data will be compared between children with iron-deficiency anemia and those without to assess the impact of anemia on physical development.
Measured: Baseline assessment and follow-up at 6 months.
Physical Growth ( Weight)
This measure evaluates children's changes in weight. Weight data will be compared between children with and without iron-deficiency anemia to assess anemia's impact on their physical development.
Measured: Baseline assessment and follow-up at 6 months.
Physical Growth (BMI)
This measure assesses children's physical growth by tracking changes in BMI. BMI (Body Mass Index) is calculated by dividing a child's weight (kg) by the square of their height (m²). BMI values will be compared between children with and without iron-deficiency anemia to evaluate anemia's impact on physical development.
Measured: Baseline assessment and follow-up at 6 months.
Eating behavior
Eating behavior was assessed using the Children's Eating Behaviour Questionnaire (CEBQ), which evaluates various aspects of children's eating habits, such as food responsiveness, enjoyment of food, and satiety responsiveness. The CEBQ scores will be compared between children with and without iron-deficiency anemia to evaluate how anemia might impact their eating behavior and, in turn, their physical development.
Measured: Collected at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Iron-Deficiency AnemiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pingshan District Maternal & Child Healthcare Hospital of Shenzhen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662045
- Sponsor's protocol ID
- 20230608
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hanson MA, Gluckman PD. Developmental origins of health and disease--global public health implications. Best Pract Res Clin Obstet Gynaecol. 2015 Jan;29(1):24-31. doi: 10.1016/j.bpobgyn.2014.06.007. Epub 2014 Aug 19.
PubMed 25225058Pala E, Erguven M, Guven S, Erdogan M, Balta T. Psychomotor development in children with iron deficiency and iron-deficiency anemia. Food Nutr Bull. 2010 Sep;31(3):431-5. doi: 10.1177/156482651003100305.
PubMed 20973463Georgieff MK. Iron assessment to protect the developing brain. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1588S-1593S. doi: 10.3945/ajcn.117.155846. Epub 2017 Oct 25.
PubMed 29070550Chikani UN, Bisi-Onyemaechi A, Ohuche I, Onu J, Ugege S, Ogugua C, Mbanefo N, Chime P, Emodi I. The effect of sickle cell anemia on the linear growth of Nigerian children. J Pediatr Endocrinol Metab. 2021 Jul 19;34(10):1283-1290. doi: 10.1515/jpem-2021-0232. Print 2021 Oct 26.
PubMed 34271599Pivina L, Semenova Y, Dosa MD, Dauletyarova M, Bjorklund G. Iron Deficiency, Cognitive Functions, and Neurobehavioral Disorders in Children. J Mol Neurosci. 2019 May;68(1):1-10. doi: 10.1007/s12031-019-01276-1. Epub 2019 Feb 18.
PubMed 30778834Yang W, Liu B, Gao R, Snetselaar LG, Strathearn L, Bao W. Association of Anemia with Neurodevelopmental Disorders in a Nationally Representative Sample of US Children. J Pediatr. 2021 Jan;228:183-189.e2. doi: 10.1016/j.jpeds.2020.09.039. Epub 2020 Oct 7.
PubMed 33035572Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013 Jul;1(1):e16-25. doi: 10.1016/S2214-109X(13)70001-9. Epub 2013 Jun 25.
PubMed 25103581
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between Iron Deficiency Anemia and Neurobehavioral Development and Cognitive Function in Children Aged 6 to 24 Months
- ClinicalTrials.gov ID
- NCT06662045
- Acronym / sponsor ID
- 20230608
- Conditions
- Iron-Deficiency Anemia, Neurobehavioral Manifestations, Growth Disorders, Nutritional Status
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pingshan District Maternal & Child Healthcare Hospital of ShenzhenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- 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 goal of this observational study is to explore the relationship between iron-deficiency anemia and neurobehavioral development in children aged 6-24 months. This study focuses on children who undergo health check-ups and blood tests at pediatric health clinics in Pingshan District, Shenzhen, China.
The main questions it aims to answer are:
How does iron-deficiency anemia affect children's neurobehavioral development, including motor skills, language ability, and social behavior? How does anemia influence growth and nutrition, such as weight, height, and body mass index (BMI) in children?
Participants will:
Undergo blood tests (including hemoglobin levels, serum ferritin, and serum iron) to assess anemia status.
Be assessed using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6" to measure motor, cognitive, language, and social development.
Provide general health information, such as birth history, feeding methods, and parental details, through interviews with trained surveyors.
Researchers will compare children with and without iron-deficiency anemia to determine differences in neurobehavioral outcomes and development levels. The findings aim to provide evidence for early interventions to prevent the negative impacts of anemia and support children's healthy development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron-Deficient Group | – | –This group consists of children diagnosed with iron-deficiency anemia. |
| Control Group (Non-Anemic) | – | –This group consists of children without iron-deficiency anemia. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- The study population will consist of children aged 6 to 24 months who attend children health care clinics for routine health check-ups and vaccinations. Participants will be recruited from both hospitals and community health centers within the designated region. The population will include children diagnosed with iron-deficiency anemia and non-anemic controls, providing a comparative sample. The study will aim to capture a diverse range of children from various socioeconomic backgrounds. Informed consent will be obtained from the parents or guardians before participation, and all children will meet the specified inclusion criteria for neurodevelopmental and physical growth evaluations.
Key inclusion criteria (6 listed)
- Children aged 6 to 24 months at the time of enrollment
- Diagnosed with iron-deficiency anemia (for the exposure group) or confirmed
- non-anemic status (for the control group) based on blood test results
- Resident in the study area for at least 6 months prior to enrollment
- Availability of parental or guardian consent to participate in the study and willingness to follow study protocols
Key exclusion criteria (7 listed)
- Presence of congenital or chronic illnesses that could affect
- neurodevelopment, such as Down syndrome or cerebral palsy.
- History of severe infections or trauma within 3 months prior to enrollment that
- could influence neurodevelopmental outcomes
- Current use of medications or treatments that may interfere with iron metabolism (e.g., iron supplementation or blood transfusions in the last 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurobehavioral Development Score
Time frame: Baseline assessment and follow-up at 6 months.
This measure assesses neurobehavioral development, including motor skills, language, social behavior, and adaptability, using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6." The score is used to determine the developmental status of children in both the iron-deficiency and non-anemic groups.
Hemoglobin (Hb)
Time frame: Blood samples will be taken at baseline and follow-up at 3 months.
To assess the severity of anemia.
Serum Ferritin
Time frame: Blood samples will be taken at baseline and follow-up at 3 months
To evaluate the iron stores in the body
4 secondary outcomes
Physical Growth (Height)
Time frame: Baseline assessment and follow-up at 6 months.
Physical Growth ( Weight)
Time frame: Baseline assessment and follow-up at 6 months.
Physical Growth (BMI)
Time frame: Baseline assessment and follow-up at 6 months.
Eating behavior
Time frame: Collected at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 25225058Hanson MA, Gluckman PD. Developmental origins of health and disease--global public health implications. Best Pract Res Clin Obstet Gynaecol. 2015 Jan;29(1):24-31. doi: 10.1016/j.bpobgyn.2014.06.007. Epub 2014 Aug 19.
- Results publication: PubMed 20973463Pala E, Erguven M, Guven S, Erdogan M, Balta T. Psychomotor development in children with iron deficiency and iron-deficiency anemia. Food Nutr Bull. 2010 Sep;31(3):431-5. doi: 10.1177/156482651003100305.
- Results publication: PubMed 29070550Georgieff MK. Iron assessment to protect the developing brain. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1588S-1593S. doi: 10.3945/ajcn.117.155846. Epub 2017 Oct 25.
- Results publication: PubMed 34271599Chikani UN, Bisi-Onyemaechi A, Ohuche I, Onu J, Ugege S, Ogugua C, Mbanefo N, Chime P, Emodi I. The effect of sickle cell anemia on the linear growth of Nigerian children. J Pediatr Endocrinol Metab. 2021 Jul 19;34(10):1283-1290. doi: 10.1515/jpem-2021-0232. Print 2021 Oct 26.
- Results publication: PubMed 30778834Pivina L, Semenova Y, Dosa MD, Dauletyarova M, Bjorklund G. Iron Deficiency, Cognitive Functions, and Neurobehavioral Disorders in Children. J Mol Neurosci. 2019 May;68(1):1-10. doi: 10.1007/s12031-019-01276-1. Epub 2019 Feb 18.
- Results publication: PubMed 33035572Yang W, Liu B, Gao R, Snetselaar LG, Strathearn L, Bao W. Association of Anemia with Neurodevelopmental Disorders in a Nationally Representative Sample of US Children. J Pediatr. 2021 Jan;228:183-189.e2. doi: 10.1016/j.jpeds.2020.09.039. Epub 2020 Oct 7.
- Results publication: PubMed 25103581Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013 Jul;1(1):e16-25. doi: 10.1016/S2214-109X(13)70001-9. Epub 2013 Jun 25.
- The Global Prevalence of Anaemia in 2011Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
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 Anemia and Neurobehavioral Manifestations, run by Pingshan District Maternal & Child Healthcare Hospital of Shenzhen 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moujinsong Project Manager, M.Sc (+86 075528799171, 582260375@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Development Score (time frame: Baseline assessment and follow-up at 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662045, which also lists 7 linked publications.
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 28 Oct 2024.