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NCT Number: NCT07665658

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Inflammation Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

Location status: Recruiting

Location contact

Dr Dur e

CONTACT

Dr Inayat Khan

CONTACT

About this study

Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Emerging evidence suggests that neuroinflammation, altered gut microbiota, and impaired neuroplasticity may contribute to ADHD pathophysiology. Nutritional interventions that target these mechanisms may provide additional therapeutic benefit.

This study is a randomized, placebo-controlled, parallel-group clinical trial designed to investigate whether supplementation with prebiotics, probiotics, omega-3 fatty acids, and vitamin B1 can improve ADHD symptoms and related biological markers in children. Sixty-eight participants aged 6 to 12 years with DSM-5 confirmed ADHD will be enrolled and randomly assigned in equal numbers to one of four intervention groups: (1) prebiotics plus probiotics, (2) omega-3 fatty acids plus vitamin B1, (3) combined supplementation, or (4) placebo.

The intervention duration will be 12 weeks. ADHD symptoms and behavioral scores will be assessed at baseline and after treatment using validated rating scales, including Conners 3 and Vanderbilt ADHD forms. Blood samples will be collected at baseline and week 12 for measurement of inflammatory and neuroplasticity biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), brain-derived neurotrophic factor (BDNF), short-chain fatty acids (SCFA), Claudin-5, and complete blood count parameters.

The primary objective is to determine the effect of supplementation on ADHD symptom scores. Secondary objectives include comparison of treatment groups for biomarker changes and evaluation of associations between biological markers and clinical outcomes. Results may help identify safe adjunctive nutritional strategies for children with ADHD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin

Dietary Supplement

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

Other names: Fructan prebiotic

Probiotic

Dietary Supplement

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

Other names: Acidophilus Bifidus

Omega-3 fatty acids

Dietary Supplement

Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.

Other names: Fish Oil, EPA, DHA

Thiamine

Dietary Supplement

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

Other names: Vitamin B1

Placebo

Other

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

Other names: Matching placebo

Primary outcomes

  1. Parent and Teacher ADHD Rating

    Time frame: Baseline and Week 12

    Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptom severity measured using the Conners 3 Parent and Teacher ADHD Rating Scales. The Conners 3 assesses inattention, hyperactivity/impulsivity, executive functioning, learning problems, aggression, and peer relations. Raw scores are converted to T-scores, with higher scores indicating greater symptom severity and functional impairment.

    Scale Information:

    T-score range: approximately 40-90 Higher scores indicate worse ADHD symptoms.

  2. Neuroinflammation Markers (IL-6, TNF-α)

    Time frame: Baseline and Week 12

    Change in serum levels of pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha measured by ELISA

  3. Neuroplasticity Markers (BDNF, Claudin-5)

    Time frame: Baseline and Week 12

    Change in brain-derived neurotrophic factor (BDNF) and blood-brain barrier tight junction protein claudin-5 measured by ELISA

  4. Short-Chain Fatty Acids (SCFA)

    Time frame: Baseline and Week 12

    Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA

  5. Complete Blood Count (CBC)

    Time frame: Baseline and Week 12

    Change in blood cell counts (e.g., white blood cells, red blood cells, platelets)

  6. ADHD Diagnostic Parent and Teacher Rating

    Time frame: Baseline and Week 12

    Change in ADHD symptom severity measured using the Vanderbilt ADHD Diagnostic Parent and Teacher Rating Scales. The symptom assessment includes 18 ADHD items corresponding to DSM criteria for inattentive and hyperactive-impulsive symptoms. Total symptom scores range from 0 to 54, with higher scores indicating greater ADHD symptom severity.

    Scale Information:

    Minimum score: 0 Maximum score: 54 Higher scores indicate worse ADHD symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Dur E Shawar, PhD*

CONTACT

[email protected]

03348405894

Prof Dr Inayat Shah, PhD

CONTACT

[email protected]

03321431414

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Khyber Teaching Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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