Attention Deficit Hyperactivity DisorderNCT01554462
The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
A study testing Eicosapentaenoic acid / Docosahexaenoic acid in people with Attention Deficit Hyperactivity Disorder and Healthy, run by Unilever R&D at 1 site in Netherlands.
Trial summary
Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Healthy
- What is being tested?
- Eicosapentaenoic acid / Docosahexaenoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Jan 2013
- 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 8 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-12 year old boys
- Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC)
- Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
- Ability to speak and comprehend Dutch.
- Used to daily consumption of margarine
- 8-12 year old boys
Show all 9Show fewer
- No DSM-IV (APA, 1994) diagnosis, according to DISC interview
- No scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form (TRF)
- Ability to speak and comprehend Dutch. 5 Used to daily consumption of margarine
Who cannot join
- mental retardation (IQ < 70)
- major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
- presence of metal objects in or around the body (pacemaker, dental braces)
- history of or present neurological disorder
- regular use of n-3 or n-6 fatty acid dietary supplements, products fortified with EPA or DHA, a regular diet high in fatty fish (= 1 serving per week) or participation in intervention studies or (school-) health programs in the four months prior to study participation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Utrecht University Medical Center; Child and adolescent psychiatry
Utrecht
About this study
Official title: The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Cognitive control functions are measured with functional Magnetic Resonance Imaging (MRI) before and after the intervention. Behavioural change is monitored with behavioural scales.
- Conditions
- Attention Deficit Hyperactivity Disorder, Healthy
- Being tested
- Eicosapentaenoic acid / Docosahexaenoic acid, Placebo dietary intervention (MUFA) in ADHD group, Placebo dietary intervention (MUFA) in healthy control group
- Keywords
- Attention, Cognitive control, ADHD, Healthy, EPA, Eicosapentaenoic acid, DHA, Docosahexaenoic acid, PUFA, Omega-3
- 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.
Eicosapentaenoic acid / Docosahexaenoic acidDietary supplement
Also called EPA, DHA
650 mg EPA + 650 mg DHA daily
Placebo dietary intervention (MUFA) in ADHD groupDietary supplement
Also called Mono Unsaturated Fatty Acid, Poly Unsaturated Fatty Acid
Placebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value
Eicosapentaenoic acid / Docosahexaenoic acidDietary supplement
Also called EPA, DHA
650 mg EPA and 650 mg DHA daily
Placebo dietary intervention (MUFA) in healthy control groupDietary supplement
Also called Mono Unsaturated Fatty Acids
Placebo contains MUFA in stead of PUFA, same energy value
| Study group | Role | What they receive |
|---|---|---|
| ADHD active | Active comparator | 4 month intervention with EPA/DHA in ADHD group Receives: Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid |
| ADHD Placebo | Placebo comparator | 4 month dietary intervention with placebo in ADHD group Receives: Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group |
| Active Healthy control | Active comparator | 4 month dietary intervention with DHA/EPA in healthy control group Receives: Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid |
| Healthy placebo | Placebo comparator | 4 month dietary intervention with placebo in healthy control group Receives: Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive control task - functional MRI
Measured: change over 16 week intervention period (pre/post)
Secondary outcomes (2)
Behavioural scales: - Child Behaviour Checklist (CBCL) / Teacher Report Form (TRF) - Strengths and Weaknesses of ADHD-symptoms and Normal behaviour (SWAN) questionnaire
Measured: Change over 16 week intervention period (pre/post)
Fatty acids status from cheek cells (swabs)
Measured: Change over 16 week intervention period (pre/post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Marco Hoeksma, PhD, Study director, Unilever Research VlaardingenSarah Durston, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554462
- Sponsor's protocol ID
- 08033V
- Status last verified
- Dec 2013
- First submitted
- 28 Feb 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- 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 37058600Bos DJ, Oranje B, Veerhoek ES, Van Diepen RM, Weusten JM, Demmelmair H, Koletzko B, de Sain-van der Velden MG, Eilander A, Hoeksma M, Durston S. Reduced Symptoms of Inattention after Dietary Omega-3 Fatty Acid Supplementation in Boys with and without Attention Deficit/Hyperactivity Disorder. Neuropsychopharmacology. 2015 Sep;40(10):2298-306. doi: 10.1038/npp.2015.73. Epub 2015 Mar 19.
PubMed 25790022
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01554462
- Acronym / sponsor ID
- 08033V
- Conditions
- Attention Deficit Hyperactivity Disorder, Healthy
- Keywords
- Attention, Cognitive control, ADHD, Healthy, EPA, Eicosapentaenoic acid, DHA, Docosahexaenoic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Mar 2012 (estimated)
- 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.
Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Cognitive control functions are measured with functional Magnetic Resonance Imaging (MRI) before and after the intervention. Behavioural change is monitored with behavioural scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADHD active | Active comparator | Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid4 month intervention with EPA/DHA in ADHD group |
| ADHD Placebo | Placebo comparator | Dietary Supplement: Placebo dietary intervention (MUFA) in ADHD group4 month dietary intervention with placebo in ADHD group |
| Active Healthy control | Active comparator | Dietary Supplement: Eicosapentaenoic acid / Docosahexaenoic acid4 month dietary intervention with DHA/EPA in healthy control group |
| Healthy placebo | Placebo comparator | Dietary Supplement: Placebo dietary intervention (MUFA) in healthy control group4 month dietary intervention with placebo in healthy control group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 8-12 year old boys
- Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC)
- Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
- Ability to speak and comprehend Dutch.
- Used to daily consumption of margarine
Key exclusion criteria (5 listed)
- mental retardation (IQ < 70)
- major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
- presence of metal objects in or around the body (pacemaker, dental braces)
- history of or present neurological disorder
- regular use of n-3 or n-6 fatty acid dietary supplements, products fortified with EPA or DHA, a regular diet high in fatty fish (= 1 serving per week) or participation in intervention studies or (school-) health programs in the four months prior to study participation.
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 |
|---|---|---|
| Eicosapentaenoic acid / Docosahexaenoic acidAlso: EPA, DHA650 mg EPA + 650 mg DHA daily | Dietary supplement | ADHD active |
| Placebo dietary intervention (MUFA) in ADHD groupAlso: Mono Unsaturated Fatty Acid, Poly Unsaturated Fatty AcidPlacebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value | Dietary supplement | ADHD Placebo |
| Eicosapentaenoic acid / Docosahexaenoic acidAlso: EPA, DHA650 mg EPA and 650 mg DHA daily | Dietary supplement | Active Healthy control |
| Placebo dietary intervention (MUFA) in healthy control groupAlso: Mono Unsaturated Fatty AcidsPlacebo contains MUFA in stead of PUFA, same energy value | Dietary supplement | Healthy placebo |
Primary outcome
Cognitive control task - functional MRI
Time frame: change over 16 week intervention period (pre/post)
2 secondary outcomes
Behavioural scales: - Child Behaviour Checklist (CBCL) / Teacher Report Form (TRF) - Strengths and Weaknesses of ADHD-symptoms and Normal behaviour (SWAN) questionnaire
Time frame: Change over 16 week intervention period (pre/post)
Fatty acids status from cheek cells (swabs)
Time frame: Change over 16 week intervention period (pre/post)
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 11 Dec 2013.
- 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.
- Derived from this study: PubMed 25790022Bos DJ, Oranje B, Veerhoek ES, Van Diepen RM, Weusten JM, Demmelmair H, Koletzko B, de Sain-van der Velden MG, Eilander A, Hoeksma M, Durston S. Reduced Symptoms of Inattention after Dietary Omega-3 Fatty Acid Supplementation in Boys with and without Attention Deficit/Hyperactivity Disorder. Neuropsychopharmacology. 2015 Sep;40(10):2298-306. doi: 10.1038/npp.2015.73. Epub 2015 Mar 19.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Marco Hoeksma, PhD study director
Unilever Research Vlaardingen
Sarah Durston, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eicosapentaenoic acid / Docosahexaenoic acid in people with Attention Deficit Hyperactivity Disorder and Healthy, run by Unilever R&D at 1 site in Netherlands.
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 9 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 11 Dec 2013. 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 Netherlands. 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?
Cognitive control task - functional MRI (time frame: change over 16 week intervention period (pre/post)). 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 NCT01554462, which also lists 2 linked publications.
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 11 Dec 2013.