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Completed

NCT Number: NCT07348562

Omega-3, Inflammation in ADHD With AI

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).

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Inflammation Mental Disorders Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

Omega-3 PUFAs

Placebo

Dietary Supplement

Olive oil

Primary outcomes

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

    Time frame: Baseline, week 1,2,4,8,12

    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.

Secondary outcomes

  1. Concentration of Peripheral Inflammatory Biomarkers

    Time frame: Baseline and week 12

    high-sensitivty C-reactive protein (hs-CRP) (milligram/Liter, mg/L) Interleukin (IL)-6 (picogram/milliliter, pg/mL)

  2. Cognitive function-Continuous Performance Test (CPT)

    Time frame: Baseline and week 12

    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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Acronym: OmInADHDAI

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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