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Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children

RecruitingNAAges 6 Years - 12 YearsAllKhyber Medical University Peshawar
NCT07665658 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled trial will evaluate the effectiveness of neuroplasticity-targeted supplements on neuroinflammatory markers and ADHD symptoms in children aged 6 to 12 years diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Participants will be randomly assigned to one of four groups: gut-targeted supplements (prebiotics and probiotics), brain-targeted supplements (omega-3 fatty acids and vitamin B1), combined supplementation, or placebo. The intervention period will last 12 weeks. Primary outcomes include changes in ADHD symptom severity and clinical scores using validated rating scales. Secondary outcomes include changes in biomarkers of neuroinflammation and neuroplasticity, including IL-6, TNF-alpha, BDNF, short-chain fatty acids, and Claudin-5.

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📋 Eligibility rules (as published)
Inclusion Criteria: * DSM-5 confirmed ADHD diagnosis * Age 6-12 years * Medication-free or on stable stimulant medication (≥1 month) Exclusion Criteria: * Antibiotic use in last 4 weeks * Gastrointestinal disorders * Neurological comorbidities (e.g., epilepsy) * Severe food allergies
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What it tests

  • Inulin
  • Probiotic
  • Omega-3 Fatty Acids
  • Thiamine
  • Placebo
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Where

1 site
Khyber Teaching Hospital
Peshawar, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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