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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorKhyber Medical University Peshawar

About this trial

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.

Eligibility criteria

Qualifiers

DSM-5 confirmed ADHD diagnosis

Age 6-12 years

Medication-free or on stable stimulant medication (≥1 month)

Disqualifiers

Antibiotic use in last 4 weeks

Gastrointestinal disorders

Neurological comorbidities (e.g., epilepsy)

Severe food allergies

Trial design

Treatments tested in this trial

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

Treatment groups

68 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Khyber Medical University Peshawar

Lead sponsor

Khyber Teaching Hospital

Collaborator