Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

NCT03542643 | Completed DMC

• 1 other identifier: CMUH104-REC2-058
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; ADHD

Keywords

ADHD; n-3 polyunsaturated fatty acids; children; adolescents

Outcome Measures

Primary Outcomes (1)

• Changes in Continuous Performance Test Raw Scores at 12 weeks

  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.

  Week 0 and Week 12

Secondary Outcomes (1)

• Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity

  Week 0, 2,4,8,12

Other Outcomes (3)

• Changes in Blood PUFAs levels at 12 Weeks

  Week 0 and Week 12

• Changes in Blood Inflammatory Markers at 12 Weeks

  Week 0 and Week 12

• Changes in Salivary Cortisol at 12 Weeks

  Week 0 and Week 12

Study Arms (2)

N-3 polyunsaturated fatty acids

ACTIVE COMPARATOR

n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA)

Dietary Supplement: n-3 Polyunsaturated fatty acid

Placebo

PLACEBO COMPARATOR

olive oil ethyl esters

Dietary Supplement: Placebo

Interventions

n-3 Polyunsaturated fatty acid DIETARY_SUPPLEMENT

1g of Eicosapentaenoic acid (EPA)

N-3 polyunsaturated fatty acids

Placebo DIETARY_SUPPLEMENT

Olive oil ethyl esters

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• King's College London: collaborator

Study Sites (1)

China Medical University

Taichung, 404, Taiwan

Location

Related Publications (1)

• Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

  PMID: 37058600 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: May 31, 2018
• Study Start: July 7, 2016
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

TW (1)