- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06504693
Iron Status in Children With ADHD
Iron Status in Children With Attention Deficit Hyperactivity Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mariam Safwat Finiar, MB.BCh
- Phone Number: 01274247710
- Email: mariamsafwat365@gmail.com
Study Contact Backup
- Name: Emad El-Deen Mahmoud Hammad, Professor
- Phone Number: 01223559943
- Email: emadhammad@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children under 4 years old
- Above 12 years old
- Not diagnosed attention deficit hyperactivity disorder(ADHD)
- Any other associated neurological disorder
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Iron status in children with attention deficit hyperactivity disorder
Time Frame: Baseline
|
To determine number of patients with ADHD who have associated iron deficiency
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Iron status in ADHD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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