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RECRUITING
NCT07665658
NA

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

Sponsor: Khyber Medical University Peshawar

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-03-01

Completion Date

2026-12-25

Last Updated

2026-06-24

Healthy Volunteers

No

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.

Locations (1)

Khyber Teaching Hospital

Peshawar, KPK, Pakistan