Omega-3, Inflammation in ADHD With AI (OmInADHDAI)

Omega-3 Fatty Acids, Inflammation and Attention Deficit Hyperactivity Disorder (ADHD) With AI (OmInADHDAI)- A Double-blind Randomized Controlled Trial of High Dose Omega-3 Fatty Acids in Children With ADHD With High Inflammation Status

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).

Study Overview

• Status: Completed
• Conditions: Adhd
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Omega-3

Detailed Description

This is a 12 week study to investigate the effects of omega-3 PUFAs in children (6-12 years-old) with ADHD.

The primary outcome will be the clinical symptoms The secondary outcomes will be inflammatory biomarkers, cognitive function and physiological markers such as heart-rate variability.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung
    • Taichung, Taichung, Taiwan, 404
      • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega-3 (DHA); DHA supplementation	Dietary supplement: Omega-3; Omega-3 PUFAs
Experimental: Omega-3 (EPA); EPA supplementation	Dietary supplement: Omega-3; Omega-3 PUFAs
Placebo Comparator: Placebo; olive oil	Dietary supplement: Placebo; Olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Peripheral Inflammatory Biomarkers	high-sensitivty C-reactive protein (hs-CRP) (milligram/Liter, mg/L) Interleukin (IL)-6 (picogram/milliliter, pg/mL)	Baseline and week 12
Cognitive function-Continuous Performance Test (CPT)	CPT is used to assess attention and impulsivity in the subjects. It involves presenting a series of stimuli (usually letters or numbers) on a screen, where the participant must respond to certain targets and ignore others, assessing their ability to sustain attention over time and control impulses. The test helps identify attention deficits, impulsivity, and response inhibition, key areas impacted in ADHD.	Baseline and week 12

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Pei-Chen Chang, MD, PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): September 4, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: children; inflammation; omega-3
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Pathological Conditions, Signs and Symptoms; Inflammation; Attention Deficit Disorder with Hyperactivity; Fatty Acids; Lipids; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Fish Oils; Docosahexaenoic Acids
• Other Study ID Numbers: CMUH109-REC2-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No