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

China Medical University

Status: Enrolling

Conditions: Adolescents; Children; ADHD

Treatments: Dietary Supplement: Omega-3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07364331

CMUH110-REC3-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

omega-3 fatty acids: EPA

Active Comparator group

Description:

EPA

Treatment:

Dietary Supplement: Omega-3

omega-3 fatty acids: DHA

Active Comparator group

Description:

DHA

Treatment:

Dietary Supplement: Omega-3

placebo

Placebo Comparator group

Description:

olive oil

Treatment:

Dietary Supplement: Placebo