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Impact of Dietary Intervention on Children of ADHD at Sohag University Hospital

S

Sohag University

Status

Not yet enrolling

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Dietary Supplement: Mediterranean diet
Dietary Supplement: Usual diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06542146
Soh-Med-24-07-2MD

Details and patient eligibility

About

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder of persistent impairment of attention, hyperactivity, and impulsivity which worsens daily functioning and quality of life , including social troubles , poor academic achievement and occupational problems .It is one of the most common psychiatric disorders between children . The prevalence of ADHD was 7.2% all over the world in 2015 and this percentage is increasing every year . In Arab countries, A systematic review of studies reported that the prevalence of ADHD ranged from 1.3% to 16%. . ADHD has been treated with medical treatment such as psychostimulants (methylphenidate and amphetamines), noradrenergic treatment as atomoxetine and alpha-2A-adrenergic agonists as guanfacine and clonidine , behavioral treatment and their combination . Due to adverse effects of medical treatments and behavioral therapy limitations, other approaches to augment multimodal ADHD management has been tested . Non medical treatment as Digital therapeutics may improve cognitive functions and attention in ADHD . Physical activity interventions for ADHD may improve cognitive , physical and psychological functions.

Enrollment

60 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 6-12 years children with ADHD

Exclusion criteria

  • patient with eating disorders.

    • patients with chronic medical illness.

    • patients with IQ below 70.

    • patients who would drop out from the study

      1. if patient would be absent for 3 months,
      2. if patient would fail for any reason to continue his dietary restriction.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

group A
Active Comparator group
Description:
patients will follow usual diet
Treatment:
Dietary Supplement: Usual diet
group B
Active Comparator group
Description:
Patients will follow Mediterranean die
Treatment:
Dietary Supplement: Mediterranean diet

Trial contacts and locations

1

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Central trial contact

Mohamed B Abdel-Azim, assistant lecutrer; Hemaid M Azab, professor

Data sourced from clinicaltrials.gov

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