AdhdOmInADHDAINCT07348562
Omega-3, Inflammation in ADHD With AI
A study testing Omega-3 in people with Adhd, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Adhd
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2021to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the 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.
- Conditions
- Adhd
- Being tested
- Omega-3, Placebo
- Keywords
- children, inflammation, omega-3
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Omega-3 PUFAs
PlaceboDietary supplement
Olive oil
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 (DHA) | Experimental | DHA supplementation Receives: Dietary Supplement: Omega-3 |
| Omega-3 (EPA) | Experimental | EPA supplementation Receives: Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | olive oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 1,2,4,8,12
Secondary outcomes (2)
Concentration of Peripheral Inflammatory Biomarkers
high-sensitivty C-reactive protein (hs-CRP) (milligram/Liter, mg/L) Interleukin (IL)-6 (picogram/milliliter, pg/mL)
Measured: 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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Feb 2021
- Primary completion4 Sep 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To investigate the effects of DHA, EPA and placebo in children and adolescents with ADHD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Chen Chang, China Medical University Hospital
- Investigators
- Pei-Chen Chang, MD, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348562
- Sponsor's protocol ID
- CMUH109-REC2-026
- Acronym
- OmInADHDAI
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07348562
- Acronym / sponsor ID
- OmInADHDAI / CMUH109-REC2-026
- Conditions
- Adhd
- Keywords
- children, inflammation, omega-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- To investigate the effects of DHA, EPA and placebo in children and adolescents with ADHD
| Arm | Type | Receives |
|---|---|---|
| Omega-3 (DHA) | Experimental | Dietary Supplement: Omega-3DHA supplementation |
| Omega-3 (EPA) | Experimental | Dietary Supplement: Omega-3EPA supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Placeboolive oil |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Omega-3 PUFAs | Dietary supplement | Omega-3 (DHA), Omega-3 (EPA) |
| PlaceboOlive oil | Dietary supplement | Placebo |
Primary outcome
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.
2 secondary outcomes
Concentration of Peripheral Inflammatory Biomarkers
Time frame: Baseline and week 12
Cognitive function-Continuous Performance Test (CPT)
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Chen Chang, MD, PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Adhd, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV) (time frame: Baseline, week 1,2,4,8,12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.