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Not yet recruiting NCT06542146

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

No phase Interventional Attention Deficit Hyperactivity Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mediterranean diet, Usual diet.
Who it may be relevant to
Registry conditions: Attention Deficit Hyperactivity Disorder. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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
  • Dietary supplement Usual diet
    Usual diet including routine diet we already eat

Primary outcome measures

  • Severity of ADHD symptoms [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Sohag university Hospital — Sohag

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06542146 · Soh-Med-24-07-2MD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗