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

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

DIETARY_SUPPLEMENT

Inulin

Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.

DIETARY_SUPPLEMENT

Probiotic

Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10\^11 CFU orally once daily for 12 weeks.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Thiamine

Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.

OTHER

Placebo

Participants will receive matching placebo supplementation orally once daily for 12 weeks.

Sponsors & Collaborators

• Khyber Teaching Hospital

  collaborator OTHER

• Khyber Medical University Peshawar

  lead OTHER

Principal Investigators

• Dr Dur E Shawar, PhD* · Khyber Medical University Peshawar, Pakistan

• Prof Dr Inayat Shah, PhD · Khyber Medical University Peshawar, Pakistan

• Prof Dr Omer Malik, PhD · Khyber Medical University Peshawar, Pakistan

• Dr Madiha Khattak, PhD · Khyber Medical College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2026-11-30

Completion

2026-12-25

Countries

• Pakistan

Study Locations