Omega-3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder (OMNeADHD) (OMNeADHD)

Omega- 3 Fatty Acids, Neuroendocrine and Attention Deficit Hyperactivity Disorder With (OMNeADHD) A Double Blind Randomized Controlled Trial of High Dose Omega- 3 Fatty Acids in Children and Adolescents With ADHD With Omega- 3 Deficiency.

This is a 12 week randomized controlled study on the effects of omega-3 fatty acids in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.

Study Overview

• Status: Recruiting
• Conditions: Children; ADHD; Adolescents
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Placebo

Detailed Description

This is a 12 week randomized controlled study on the effects of omega-3 fatty acids (EPA or DHA) in youth with attention deficit hyperactivity disorder (ADHD) with omega-3 deficiency.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Chen Chang, PhD; Phone Number: 14126 +88622052121; Email: 013121@tool.caaumed.org.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospital
    • Contact: Pei-Chen Chang, PhD; Phone Number: 886 4 22052121; Email: 013121@tool.caaumed.org.tw
    • Principal Investigator: Pei-chen Chang, PD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. DSM-5 diagnosis of ADHD
2. Did not have any changes of ADHD treatment (pharmacological/psychological) within 4 weeks of entering the trial.
3. SNAP-IV inattention subscale >=12, or hyperactivity subscale >=12, or inattention+ hyperactivity subscales >=24

Exclusion Criteria:

1. IQ<80
2. Allergic to omega-3
3. Physical disorders: thyroid function, cancer
4. Psychiatric comorbidity: SUD, psychotic disorders, bipolar disorder, major depressive disorder

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
Placebo Comparator: placebo; olive oil	Dietary supplement: Placebo; olive oil
Active Comparator: omega-3 fatty acids: EPA; EPA	Dietary supplement: Omega-3; EPA or DHA
Active Comparator: omega-3 fatty acids: DHA; DHA	Dietary supplement: Omega-3; EPA or DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical symptoms-attention and impulsivity symptom severity	The Swanson, Nolan, and Pelham Rating Scale- 4th edition (SNAP-IV) is used to help 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.	week 0,1,2,4,8,12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of cognitive function: attention and impulsivity	The Continuous Performance Test (CPT) will be used to measure attention and impulse control of the subjects. During the test, individuals are presented with a series of stimuli and must respond to specific targets while ignoring distractions. It is commonly used to assess attention deficits and impulsivity, key symptoms in ADHD.	week 0,12
Concentration of Peripheral cortisol levels	saliva and blood samples will be taken to assess peripheral cortisol levels. (micrograms/deciliter, μg/dL)	week 0,12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; children; adolescents; omega-3; epa; dha
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; 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: CMUH110-REC3-203

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