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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV)
Study Overview
Brief 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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
double blind
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Omega-3 (DHA)
DHA supplementation
Intervention: Omega-3 (Dietary Supplement)
Omega-3 (EPA)
EPA supplementation
Intervention: Omega-3 (Dietary Supplement)
Placebo
olive oil
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Concentration of Peripheral Inflammatory Biomarkers(Baseline and week 12)
- Cognitive function-Continuous Performance Test (CPT)(Baseline and week 12)
Investigators
Pei-Chen Chang
Attending Physician
China Medical University Hospital