Attention Deficit Hyperactivity DisorderNCT06504693
Iron Status in Children With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
Trial summary
Evaluation of the status of iron deficiency in children with attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- CBC
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to Oct 2025
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: All children above 4 years and under 12 years old diagnosed with attention deficit hyperactivity disorder (ADHD)
Who may be able to join
- All children above 4 years and under 12 years old diagnosed with attention deficit hyperactivity disorder (ADHD) according to DSM-V criteria.
- Not receiving iron therapy
Who cannot join
- Children under 4 years old
- Above 12 years old
- Not diagnosed attention deficit hyperactivity disorder(ADHD)
- Any other associated neurological disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Iron Status in Children With Attention Deficit Hyperactivity Disorder
Evaluation of the status of iron deficiency in children with attention deficit hyperactivity disorder.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders, affecting ~5-8% of children worldwide. For about 60% children with ADHD, the symptoms persist into adulthood. Individuals with ADHD have poorer educational and social outcomes, increased injury incidences during daily activities and an elevated risk of developing more severe mental disorders.
Attention deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder defined by persistent, impairing and developmentally inappropriate inattentive/disorganized and/or hyperactive/impulsive behaviors that lie at the far end of a normally distributed continuum.
Dopamine is one of the key neurotransmitters in the brain. Besides its regulatory role in motor and limbic functions, dopamine also regulates cognition, attention, and reward, each of which is impaired in ADHD. The nigrostriatal dopamine pathway is involved in motor control, while the mesolimbic dopamine pathway is involved in motivation and reinforcement learning. The mesocortical dopamine pathway originating in the ventral tegmental area (VTA) and projecting to the prefrontal cortex (PFC) plays a role in cognitive functioning.
Brain iron homeostasis may be important in the pathophysiology of ADHD because iron is a cofactor of the rate-limiting enzyme tyrosine hydroxylase, which is required for dopamine synthesis in the metabolism of dopamine and the hypodopaminergic state of the brain in ADHD results in the symptoms of the disorder. Moreover, iron is colocalized with dopamine in the brain of children with ADHD.
In children, iron deficiency can therefore lead to delayed cognitive, motor, attention and memory deficits, visual and auditory deficits, decreased school performance, and/or behavioral disorders, some with persistent long-term effects.
WHO defines anemia in a population as a mild, moderate, or severe public health problem if its prevalence is 5-20%, 20-40%, or >40%, respectively. Most of the WHO countries have a moderate-to-severe public health problem with anemia, i.e., over 20% of women and young children are affected. In developing countries, diets with poor iron bioavailability are the primary cause of iron deficiency anemia.
There is a high demand for dietary iron during infancy and preschool years to support physical growth, rapid brain development, and early learning capacity.Prompt identification and treatment of anemia leads to overall improvement of population health outcomes, improved physical exercise performance, and well-being that results in enhanced economic productivity.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- CBC
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCDiagnostic test
Also called Serum ferritin level, Serum iron level
diagnostic tests for iron status
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status in children with attention deficit hyperactivity disorder
To determine number of patients with ADHD who have associated iron deficiency
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Safwat Finiar Fanous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504693
- Sponsor's protocol ID
- Iron status in ADHD
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mantadakis E, Chatzimichael E, Zikidou P. Iron Deficiency Anemia in Children Residing in High and Low-Income Countries: Risk Factors, Prevention, Diagnosis and Therapy. Mediterr J Hematol Infect Dis. 2020 Jul 1;12(1):e2020041. doi: 10.4084/MJHID.2020.041. eCollection 2020.
PubMed 32670519
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Status in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06504693
- Acronym / sponsor ID
- Iron status in ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Jul 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.
Evaluation of the status of iron deficiency in children with attention deficit hyperactivity disorder.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders, affecting ~5-8% of children worldwide. For about 60% children with ADHD, the symptoms persist into adulthood. Individuals with ADHD have poorer educational and social outcomes, increased injury incidences during daily activities and an elevated risk of developing more severe mental disorders.
Attention deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder defined by persistent, impairing and developmentally inappropriate inattentive/disorganized and/or hyperactive/impulsive behaviors that lie at the far end of a normally distributed continuum.
Dopamine is one of the key neurotransmitters in the brain. Besides its regulatory role in motor and limbic functions, dopamine also regulates cognition, attention, and reward, each of which is impaired in ADHD. The nigrostriatal dopamine pathway is involved in motor control, while the mesolimbic dopamine pathway is involved in motivation and reinforcement learning. The mesocortical dopamine pathway originating in the ventral tegmental area (VTA) and projecting to the prefrontal cortex (PFC) plays a role in cognitive functioning.
Brain iron homeostasis may be important in the pathophysiology of ADHD because iron is a cofactor of the rate-limiting enzyme tyrosine hydroxylase, which is required for dopamine synthesis in the metabolism of dopamine and the hypodopaminergic state of the brain in ADHD results in the symptoms of the disorder. Moreover, iron is colocalized with dopamine in the brain of children with ADHD.
In children, iron deficiency can therefore lead to delayed cognitive, motor, attention and memory deficits, visual and auditory deficits, decreased school performance, and/or behavioral disorders, some with persistent long-term effects.
WHO defines anemia in a population as a mild, moderate, or severe public health problem if its prevalence is 5-20%, 20-40%, or >40%, respectively. Most of the WHO countries have a moderate-to-severe public health problem with anemia, i.e., over 20% of women and young children are affected. In developing countries, diets with poor iron bioavailability are the primary cause of iron deficiency anemia.
There is a high demand for dietary iron during infancy and preschool years to support physical growth, rapid brain development, and early learning capacity.Prompt identification and treatment of anemia leads to overall improvement of population health outcomes, improved physical exercise performance, and well-being that results in enhanced economic productivity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children above 4 years and under 12 years old diagnosed with attention deficit hyperactivity disorder (ADHD)
Key inclusion criteria (2 listed)
- All children above 4 years and under 12 years old diagnosed with attention deficit hyperactivity disorder (ADHD) according to DSM-V criteria.
- Not receiving iron therapy
Key exclusion criteria (4 listed)
- Children under 4 years old
- Above 12 years old
- Not diagnosed attention deficit hyperactivity disorder(ADHD)
- Any other associated neurological disorder
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 |
|---|---|---|
| CBCAlso: Serum ferritin level, Serum iron leveldiagnostic tests for iron status | Diagnostic test | – |
Primary outcome
Iron status in children with attention deficit hyperactivity disorder
Time frame: Baseline
To determine number of patients with ADHD who have associated iron deficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 32670519Mantadakis E, Chatzimichael E, Zikidou P. Iron Deficiency Anemia in Children Residing in High and Low-Income Countries: Risk Factors, Prevention, Diagnosis and Therapy. Mediterr J Hematol Infect Dis. 2020 Jul 1;12(1):e2020041. doi: 10.4084/MJHID.2020.041. eCollection 2020.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
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 2 inclusion and 4 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Mariam Safwat Finiar, MB.BCh (01274247710, mariamsafwat365@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status in children with attention deficit hyperactivity disorder (time frame: Baseline). 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 NCT06504693, which also lists 1 linked publication.
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 17 Jul 2024.