Health TrialsbyHealthPanel

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

ConditionAttention Deficit Hyperactivity Disorder
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Probiotic

    Dietary supplement

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

  • 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.

  • Thiamine

    Dietary supplement

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

  • Placebo

    Other intervention

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

Treatment groups

68 Participants
are divided into 4 treatment groups
Group A: Gut-Targeted Supplements GroupExperimental treatment 2 interventions
Group B: Neuroplasticity-Targeted Supplements GroupExperimental treatment 2 interventions
Group C: Combined Supplements GroupExperimental treatment 4 interventions
Group D: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Parent and Teacher ADHD Rating

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.

Time frame
Baseline and Week 12
2

Neuroinflammation Markers (IL-6, TNF-α)

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

Time frame
Baseline and Week 12
3

Neuroplasticity Markers (BDNF, Claudin-5)

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

Time frame
Baseline and Week 12
4

Short-Chain Fatty Acids (SCFA)

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

Time frame
Baseline and Week 12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Khyber Medical University Peshawar

Lead sponsor

Khyber Teaching Hospital

Collaborator

Source ClinicalTrials.gov
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