Omega-3, Inflammation in ADHD With AI (OmInADHDAI)

China Medical University

Status: Completed

Conditions: Adhd

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07348562

CMUH109-REC2-026

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

Omega-3 (DHA)

Experimental group

Description:

DHA supplementation

Treatment:

Dietary Supplement: Omega-3

Omega-3 (EPA)

Experimental group

Description:

EPA supplementation

Treatment:

Dietary Supplement: Omega-3

Placebo

Placebo Comparator group

Description:

olive oil

Treatment:

Dietary Supplement: Placebo