Omega-3, Inflammation in ADHD With AI

NCT07348562 | Completed

• 1 other identifier: CMUH109-REC2-026
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12 week study to investigate the effects of omega-3 polyunsaturated fatty acids (PUFAs) in children with attention deficit hyperactivity disorder (ADHD).

Conditions

Adhd

Keywords

children; inflammation; omega-3

Outcome Measures

Primary Outcomes (1)

• Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV)

  The SNAP-IV is used assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.

  Baseline, week 1,2,4,8,12

Secondary Outcomes (2)

• Concentration of Peripheral Inflammatory Biomarkers

  Baseline and week 12

• Cognitive function-Continuous Performance Test (CPT)

  Baseline and week 12

Study Arms (3)

Omega-3 (DHA)

EXPERIMENTAL

DHA supplementation

Dietary Supplement: Omega-3

Omega-3 (EPA)

EXPERIMENTAL

EPA supplementation

Dietary Supplement: Omega-3

Placebo

PLACEBO COMPARATOR

olive oil

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

Omega-3 PUFAs

Omega-3 (DHA); Omega-3 (EPA)

Placebo DIETARY_SUPPLEMENT

Olive oil

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of ADHD (DSM-5) made by a child and adolescent psychiatrist.
• Age range: 6-12 years old at the time of enrollment.
• SNAP-IV (Mandarin Chinese Version):
• Inattention subscale score \> 12 or Hyperactivity/impulsivity subscale score \> 12 or Total score \> 24
• Drug-naïve or no ADHD medication use in the past 6 months.
• Signed informed consent required.

You may not qualify if:

• Intelligence quotient \<80
• Comorbid other psychiatric disorders, such as autism spectrum disorder, anxiety disorder, conduct disorder, schizophrenia, mood disorder
• Comorbid physical disorders, such as thyroid dysfunction, cerebral palsy, coagulation disorders
• Currently using omega-3 supplements
• Allergy to omega-3

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Inflammation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Pei-Chen Chang, MD, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: To investigate the effects of DHA, EPA and placebo in children and adolescents with ADHD

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: January 16, 2026
• Study Start: February 1, 2021
• Primary Completion: September 4, 2021
• Study Completion: November 20, 2021
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)