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Not yet recruitingNCT06504693Updated Jul 17, 2024

Iron Status in Children With ADHD

An observational study in Attention Deficit Hyperactivity Disorder, sponsored by Assiut University. Not yet recruiting. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
44
Ages
4 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All children above 4 years and under 12 years old diagnosed with attention deficit hyperactivity disorder (ADHD)

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

Exclusion Criteria:

  • Children under 4 years old
  • Above 12 years old
  • Not diagnosed attention deficit hyperactivity disorder(ADHD)
  • Any other associated neurological disorder
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
44 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testCBC

    diagnostic tests for iron status

    Also known as: Serum ferritin level, Serum iron level

05

What researchers measure

Primary outcomes

  1. Iron status in children with attention deficit hyperactivity disorder

    To determine number of patients with ADHD who have associated iron deficiency

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT06504693
Lead sponsor
Assiut University
Responsible party
Mariam Safwat Finiar Fanous (Doctor, Assiut University) — Principal investigator
First posted
Jul 17, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Jul 17, 2024

Study contacts

Mariam Safwat Finiar, MB.BCh
Contact
mariamsafwat365@gmail.com
01274247710
Emad El-Deen Mahmoud Hammad, Professor
Contact
emadhammad@aun.edu.eg
01223559943

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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