Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder, Randomized Controlled Trial, Neuroinflammation, Neuroplasticity
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTInulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
DIETARY_SUPPLEMENTProbiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10\^11 CFU orally once daily for 12 weeks.
DIETARY_SUPPLEMENTOmega-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_SUPPLEMENTThiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
OTHERPlacebo
Participants will receive matching placebo supplementation orally once daily for 12 weeks.
Sponsors
Khyber Medical University Peshawar
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to one of four parallel groups: (1) prebiotics plus probiotics, (2) omega-3 fatty acids plus vitamin B1, (3) combined supplementation, or (4) placebo. Participants will remain in their assigned group throughout the 12-week intervention period.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent and Teacher ADHD Rating | 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. |
| Neuroinflammation Markers (IL-6, TNF-α) | Baseline and Week 12 | Change in serum levels of pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha measured by ELISA |
| Neuroplasticity Markers (BDNF, Claudin-5) | Baseline and Week 12 | Change in brain-derived neurotrophic factor (BDNF) and blood-brain barrier tight junction protein claudin-5 measured by ELISA |
| Short-Chain Fatty Acids (SCFA) | Baseline and Week 12 | Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA |
| Complete Blood Count (CBC) | Baseline and Week 12 | Change in blood cell counts (e.g., white blood cells, red blood cells, platelets) |
| ADHD Diagnostic Parent and Teacher Rating | 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. |
Countries
Pakistan
Contacts
CONTACTDr Dur E Shawar, PhD*
CONTACTProf Dr Inayat Shah, PhD
PRINCIPAL_INVESTIGATORDr Dur E Shawar, PhD*
Khyber Medical University Peshawar, Pakistan
PRINCIPAL_INVESTIGATORProf Dr Inayat Shah, PhD
Khyber Medical University Peshawar, Pakistan
PRINCIPAL_INVESTIGATORProf Dr Omer Malik, PhD
Khyber Medical University Peshawar, Pakistan
PRINCIPAL_INVESTIGATORDr Madiha Khattak, PhD
Khyber Medical College
Outcome results
None listed