Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD
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|ClinicalTrials.gov Identifier: NCT03542643|
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder ADHD||Dietary Supplement: n-3 Polyunsaturated fatty acid Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder|
|Actual Study Start Date :||July 7, 2016|
|Actual Primary Completion Date :||December 11, 2017|
|Actual Study Completion Date :||December 11, 2017|
Active Comparator: N-3 polyunsaturated fatty acids
n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA)
Dietary Supplement: n-3 Polyunsaturated fatty acid
1g of Eicosapentaenoic acid (EPA)
Placebo Comparator: Placebo
olive oil ethyl esters
Dietary Supplement: Placebo
Olive oil ethyl esters
- Changes in Continuous Performance Test Raw Scores at 12 weeks [ Time Frame: Week 0 and Week 12 ]
Correct Detection: This indicates the number of times the client responded to the target stimulus. Higher rates of correct detections indicate better attentional capacity.
Reaction times: This measures the amount of time between the presentation of the stimulus and the client's response.
Omission errors: This indicates the number of times the target was presented, but the client did not respond/click the mouse. High omission rates indicate that the subject is either not paying attention (distractibility) to stimuli or has a sluggish response.
Commission errors: This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general.
- Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity [ Time Frame: Week 0, 2,4,8,12 ]Inattention: items 1-9 Hyperactivity: items 10-18 Total ADHD: items 1-18 the greater the scores on SNAP-IV indicate the greater the severity of ADHD symptoms
- Changes in Blood PUFAs levels at 12 Weeks [ Time Frame: Week 0 and Week 12 ]measurement of blood PUFAs levels
- Changes in Blood Inflammatory Markers at 12 Weeks [ Time Frame: Week 0 and Week 12 ]measurements of blood inflammatory markers
- Changes in Salivary Cortisol at 12 Weeks [ Time Frame: Week 0 and Week 12 ]measurements of salivary cortisol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542643
|China Medical University|
|Taichung, Taiwan, 404|