Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trials

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Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• DSM-5 confirmed ADHD diagnosis

• Age 6-12 years

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

Locations
Other Locations
Pakistan
Khyber Teaching Hospital
RECRUITING
Peshawar
Contact Information
Primary
Dr Dur E Shawar, PhD*
shehwar88@gmail.com
03348405894
Backup
Prof Dr Inayat Shah, PhD
inayat.shah@kmu.edu.pk
03321431414
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2026-12-25
Participants
Target number of participants: 68
Treatments
Experimental: Gut-Targeted Supplements Group
Participants will receive prebiotics (inulin 6 g/day) and probiotics (Acidophilus Bifidus 2 × 10\^11 CFU/day orally) for 12 weeks.
Experimental: Neuroplasticity-Targeted Supplements Group
Participants will receive omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, plus vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
Experimental: Combined Supplements Group
Participants will receive prebiotics (inulin 6 g/day), probiotics (Acidophilus Bifidus 2 × 10\^11 CFU/day), omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, and vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
Placebo_comparator: Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
Sponsors
Collaborators: Khyber Teaching Hospital
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov