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Attention Deficit Hyperactivity DisorderNCT06504693

Iron Status in Children With ADHD

An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mariam Safwat Finiar, MB.BCh contact

01274247710

mariamsafwat365@gmail.com

Emad El-Deen Mahmoud Hammad, Professor contact

01223559943

emadhammad@aun.edu.eg

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.

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.

  1. 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.

  1. First posted17 Jul 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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)
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

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.

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Iron Status in Children With ADHD (NCT06504693) | AzTrials