Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

NCT ID: NCT03542643

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-07
• Study Completion Date: 2017-12-11

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.

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.

Conditions

Attention Deficit Hyperactivity Disorder; ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

N-3 polyunsaturated fatty acids

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

Group Type: ACTIVE_COMPARATOR

n-3 Polyunsaturated fatty acid

Intervention Type: DIETARY_SUPPLEMENT

1g of Eicosapentaenoic acid (EPA)

Placebo

olive oil ethyl esters

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Olive oil ethyl esters

Interventions

n-3 Polyunsaturated fatty acid

1g of Eicosapentaenoic acid (EPA)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Olive oil ethyl esters

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 37058600 (View on PubMed)

Other Identifiers

CMUH104-REC2-058

Identifier Type: -

Identifier Source: org_study_id