Omega-3 fatty acids for ADHD in children and teens with low omega-3
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 trial tests whether taking EPA or DHA supplements for 12 weeks helps children and adolescents with ADHD who have low omega-3 levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT07364331 on ClinicalTrials.gov |
What this trial studies
This is a 12-week randomized, placebo-controlled trial enrolling children and adolescents diagnosed with ADHD who also have omega-3 deficiency. Participants who have had no changes in ADHD treatment for at least 4 weeks are randomized to receive EPA, DHA, or a placebo. Symptom thresholds for enrollment use the SNAP-IV inattentive and hyperactive subscales, and outcomes will compare ADHD symptoms between active and placebo groups over 12 weeks. The trial is conducted at China Medical University Hospital with standard safety exclusions for medical and major psychiatric comorbidities.
Who should consider this trial
Good fit: Children and adolescents with a DSM-5 diagnosis of ADHD, documented low omega-3 levels, stable ADHD treatment for at least 4 weeks, and SNAP-IV scores meeting the entry thresholds are ideal candidates.
Not a fit: Those with IQ below 80, allergy to omega-3, significant medical disorders (e.g., thyroid cancer), or major psychiatric comorbidities are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, omega-3 supplementation could offer a low-risk option to reduce ADHD symptoms in youth with documented omega-3 deficiency.
How similar studies have performed: Previous trials of omega-3 supplements for pediatric ADHD have shown mixed but modest benefits, so this approach has some supportive but inconsistent evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Pei-Chen Chang, PhD — China Medical University Hospital
- Study coordinator: Pei-Chen Chang, PhD
- Email: 013121@tool.caaumed.org.tw
- Phone: +88622052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.