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NCT Number: NCT06542146

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university Hospital

Sohag, Egypt

Location contact

Magdy M Amin, professor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean diet

Dietary Supplement

The Mediterranean diet is consisting of fruits, vegetables , legumes, whole grains, nuts, and olive oil as the main source ofdietary fat

Usual diet

Dietary Supplement

Usual diet including routine diet we already eat

Primary outcomes

  1. Severity of ADHD symptoms

    Time frame: 6 months

    WEISS functional impairment rating scale-parent form (WFIRS-P) to assess the severity of ADHD symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Hemaid M Azab, professor

CONTACT

Mohamed B Abdel-Azim, assistant lecutrer

CONTACT

[email protected]

01094460977

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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