Attention Deficit Hyperactivity DisorderEFANCT01055119
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
A study testing Omega-3 fatty acids in people with Attention Deficit Hyperactivity Disorder, run by University of Ulm at 2 sites in Germany.
Trial summary
The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2009to Sep 2012
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis
- Age 9-12y
- Native German speaker
Who cannot join
- Allergy against fish and fish products
- IQ below 85
- Objections against pork gelatine
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik fuer Psychiatrie und Psychotherapie III
Ulm, Baden-Wurttemberg, 89075
Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III
Ulm, D-89075
About this study
Official title: Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Omega-3 fatty acids
- 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.
Omega-3 fatty acidsDietary supplement
duration: 4 month
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acids | Active comparator | Not described Receives: Dietary Supplement: Omega-3 fatty acids |
| Olive oil | Placebo comparator | Not described Receives: Dietary Supplement: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior, Cognition
Measured: Before intervention and 16 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Widenhorn-Mueller, University of Ulm
- Investigators
- Bode Harald, MD, Principal investigator, Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055119
- Sponsor's protocol ID
- ADHD PUFA 2009
- Acronym
- EFA
- Status last verified
- May 2013
- First submitted
- 22 Jan 2010
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01055119
- Acronym / sponsor ID
- EFA / ADHD PUFA 2009
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Jan 2010 (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.
The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acids | Active comparator | Dietary Supplement: Omega-3 fatty acids |
| Olive oil | Placebo comparator | Dietary Supplement: Omega-3 fatty acids |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ADHD diagnosis
- Age 9-12y
- Native German speaker
Key exclusion criteria (3 listed)
- Allergy against fish and fish products
- IQ below 85
- Objections against pork gelatine
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 |
|---|---|---|
| Omega-3 fatty acidsduration: 4 month | Dietary supplement | Olive oil, Omega-3 fatty acids |
Primary outcome
Behavior, Cognition
Time frame: Before intervention and 16 weeks after start of intervention
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 3 May 2013.
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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.
Bode Harald, MD principal investigator
Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids in people with Attention Deficit Hyperactivity Disorder, run by University of Ulm at 2 sites in Germany.
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 3 inclusion and 3 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 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Behavior, Cognition (time frame: Before intervention and 16 weeks after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2013.