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

August 4, 2024 updated by: Mohamed Bahaa Abdelazeem, Sohag University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hemaid M Azab, professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
patients will follow usual diet
Dietary supplement: Usual diet
Usual diet including routine diet we already eat
Active Comparator: group B
Patients will follow Mediterranean die
Dietary supplement: Mediterranean diet
The Mediterranean diet is consisting of fruits, vegetables , legumes, whole grains, nuts, and olive oil as the main source ofdietary fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of ADHD symptoms
Time Frame: 6 months
WEISS functional impairment rating scale-parent form (WFIRS-P) to assess the severity of ADHD symptoms
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 4, 2024

First Submitted That Met QC Criteria

August 4, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 4, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-07-2MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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