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Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children
Sponsor: Khyber Medical University Peshawar
Summary
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.
Official title: Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-03-01
Completion Date
2026-12-25
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10\^11 CFU orally once daily for 12 weeks.
Omega-3 Fatty Acids
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
Placebo
Participants will receive matching placebo supplementation orally once daily for 12 weeks.
Locations (1)
Khyber Teaching Hospital
Peshawar, KPK, Pakistan