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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 (DHA) | Experimental | DHA supplementation |
|
| Omega-3 (EPA) | Experimental | EPA supplementation |
|
| Placebo | Placebo Comparator | olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | Omega-3 PUFAs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 1,2,4,8,12 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Peripheral Inflammatory Biomarkers | high-sensitivty C-reactive protein (hs-CRP) (milligram/Liter, mg/L) Interleukin (IL)-6 (picogram/milliliter, pg/mL) | Baseline and week 12 |
| Cognitive function-Continuous Performance Test (CPT) |
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Inclusion Criteria:
Inattention subscale score > 12 or Hyperactivity/impulsivity subscale score > 12 or Total score > 24
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pei-Chen Chang, MD, PhD | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Taichung | Taichung | 404 | Taiwan |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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To investigate the effects of DHA, EPA and placebo in children and adolescents with ADHD
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double blind
| Placebo |
| Dietary Supplement |
Olive oil |
|
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.
| Baseline and week 12 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |