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

NCT06542146 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-07-2MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Severity of ADHD symptoms

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

  6 months

Study Arms (2)

group A

ACTIVE COMPARATOR

patients will follow usual diet

Dietary Supplement: Usual diet

group B

ACTIVE COMPARATOR

Patients will follow Mediterranean die

Dietary Supplement: Mediterranean diet

Interventions

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

group B

Usual diet DIETARY_SUPPLEMENT

Usual diet including routine diet we already eat

group A

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years children with ADHD

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

• Polanczyk GV, Willcutt EG, Salum GA, Kieling C, Rohde LA. ADHD prevalence estimates across three decades: an updated systematic review and meta-regression analysis. Int J Epidemiol. 2014 Apr;43(2):434-42. doi: 10.1093/ije/dyt261. Epub 2014 Jan 24.

  PMID: 24464188 BACKGROUND

• Christiansen L, Beck MM, Bilenberg N, Wienecke J, Astrup A, Lundbye-Jensen J. Effects of Exercise on Cognitive Performance in Children and Adolescents with ADHD: Potential Mechanisms and Evidence-based Recommendations. J Clin Med. 2019 Jun 12;8(6):841. doi: 10.3390/jcm8060841.

  PMID: 31212854 BACKGROUND

• Chen HJ, Lee YJ, Yeh GC, Lin HC. Association of attention-deficit/hyperactivity disorder with diabetes: a population-based study. Pediatr Res. 2013 Apr;73(4 Pt 1):492-6. doi: 10.1038/pr.2013.5. Epub 2013 Jan 17.

  PMID: 23329200 BACKGROUND

• Arnold LE, Kleykamp D, Votolato NA, Taylor WA, Kontras SB, Tobin K. Gamma-linolenic acid for attention-deficit hyperactivity disorder: placebo-controlled comparison to D-amphetamine. Biol Psychiatry. 1989 Jan 15;25(2):222-8. doi: 10.1016/0006-3223(89)90167-4.

  PMID: 2539203 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Mohamed B Abdel-Azim, assistant lecutrer

CONTACT

01094460977; mohamed_ahmed11@med.sohag.edu.eg

Hemaid M Azab, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecteurer neuropsychiatry department sohag univerisity hospital

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

EG (1)