Attention Deficit Hyperactivity DisorderNCT03542643
Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD
A study testing n-3 Polyunsaturated fatty acid in people with Attention Deficit Hyperactivity Disorder and ADHD, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, ADHD
- What is being tested?
- n-3 Polyunsaturated fatty acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2016to 11 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder
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.
Read the 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
- Being tested
- n-3 Polyunsaturated fatty acid, Placebo
- Keywords
- ADHD, n-3 polyunsaturated fatty acids, children, adolescents
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 Polyunsaturated fatty acidDietary supplement
1g of Eicosapentaenoic acid (EPA)
PlaceboDietary supplement
Olive oil ethyl esters
| Study group | Role | What they receive |
|---|---|---|
| N-3 polyunsaturated fatty acids | Active comparator | n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA) Receives: Dietary Supplement: n-3 Polyunsaturated fatty acid |
| Placebo | Placebo comparator | olive oil ethyl esters Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and Week 12
Secondary outcomes (1)
Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity
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
Measured: Week 0, 2,4,8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start7 Jul 2016
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542643
- Sponsor's protocol ID
- CMUH104-REC2-058
- Status last verified
- Jun 2018
- First submitted
- 20 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37058600
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03542643
- Acronym / sponsor ID
- CMUH104-REC2-058
- Conditions
- Attention Deficit Hyperactivity Disorder, ADHD
- Keywords
- ADHD, n-3 polyunsaturated fatty acids, children, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, King's College London
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-3 polyunsaturated fatty acids | Active comparator | Dietary Supplement: n-3 Polyunsaturated fatty acidn-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA) |
| Placebo | Placebo comparator | Dietary Supplement: Placeboolive oil ethyl esters |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 Polyunsaturated fatty acid1g of Eicosapentaenoic acid (EPA) | Dietary supplement | N-3 polyunsaturated fatty acids |
| PlaceboOlive oil ethyl esters | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity
Time frame: Week 0, 2,4,8,12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Derived from this study: PubMed 37058600Gillies 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 Polyunsaturated fatty acid in people with Attention Deficit Hyperactivity Disorder and ADHD, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Continuous Performance Test Raw Scores at 12 weeks (time frame: Week 0 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.