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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
Sponsor:
Collaborators:
National Science Council, Taiwan
King's College London
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:
N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and crucial for the developing brain. Deficiency in n-3 PUFAs might be linked to the poor cognitive performances resulting in inattention and hyperactivity in youth with attention deficit hyperactivity disorder (ADHD). N-3 PUFAs appears to be a promising treatment that is safe, beneficial to youth with ADHD. In this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in improving cognitive function in youth with ADHD after 12 weeks of intervention.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder ADHD Dietary Supplement: n-3 Polyunsaturated fatty acid Dietary Supplement: Placebo Not Applicable

Detailed Description:
This is a 1-year study and a randomized, double-blind, and placebo controlled Clinical the study. investigators plan to enrol 100 subjects from Child and Adolescent Psychiatry Outpatient Clinic of China Medical University Hospital.Participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks. Evaluation of the cognitive function ( using Continuous Performance Test 3rd Edition ) of the subjects who are enrolled into the study will take place at baseline and after the 12th week. The symptom severity of ADHD will be measured with Swanson, Nolan, Pelham Questionnaire (SNAP-IV) at baseline, 2,4,8, and 12 weeks. The plasma level of n-3 polyunsaturated fatty acids, blood and salivary inflammatory markers will also be measured at the beginning and at the end of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Changes in Blood PUFAs levels at 12 Weeks [ Time Frame: Week 0 and Week 12 ]
    measurement of blood PUFAs levels

  2. Changes in Blood Inflammatory Markers at 12 Weeks [ Time Frame: Week 0 and Week 12 ]
    measurements of blood inflammatory markers

  3. Changes in Salivary Cortisol at 12 Weeks [ Time Frame: Week 0 and Week 12 ]
    measurements of salivary cortisol



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-5 diagnosed ADHD
  • Age 6-18 years old at time of enrolment
  • Conner's rating scares (CPRS) with scores >= 2 standard deviations
  • drug native or no medication use for past 6 months
  • Signed informed consent

Exclusion Criteria:

  • Intelligence quotient <70
  • Comorbid other psychiatric disorders, such as autism spectrum disorders, anxiety disorders, conduct disorders, schizophrenia, major depressive disorders and bipolar spectrum disorders
  • Comorbid physical disorders, such as thyroid dysfunction, cerebral palsy
  • Current using omega-3 supplements
  • Allergy to omega-3

Information from the National Library of Medicine

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


Locations
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Taiwan
China Medical University
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
National Science Council, Taiwan
King's College London

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03542643     History of Changes
Other Study ID Numbers: CMUH104-REC2-058
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
ADHD
n-3 polyunsaturated fatty acids
children
adolescents
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms