Omega-3, Inflammation in ADHD With AI

China Medical University Hospital15 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Adhd

Interventions

Omega-3DIETARY_SUPPLEMENT

Omega-3 PUFAs

PlaceboDIETARY_SUPPLEMENT

Olive oil

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

China Medical University

Taichung, Taichung, Taiwan

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Concentration of Peripheral Inflammatory Biomarkers

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

Time frame: 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.

Time frame: Baseline and week 12

Data from ClinicalTrials.gov

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