Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the StudyNCT01795040
Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD
A study testing omega-3/omega-6 fatty acids (PUFAs) in people with Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study, run by University of Cologne at 1 site in Germany.
Trial summary
The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study
- What is being tested?
- omega-3/omega-6 fatty acids (PUFAs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to May 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 3 - 6 years
- Visit of a preschool (Kindergarten)
- Parents have a command of the German language
- Screening score >90th percentile in a combined parent and teacher screening questionnaire
Who cannot join
- Hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine)
- Consumption of omega fatty acids preparation
- Consumption of fish oil-capsules
Trial locations and contacts
1 site in 1 country.
Manfred Doepfner, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Department of Child and Adolescent Psychiatry at the University Cologne
Cologne
Manfred Doepfner, Prof. Dr., Manfred.doepfner@uk-koeln.de
About this study
Official title: Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD
The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
Read the detailed description
The study aims at the reduction of hyperactivity, inattention and impulsivity in pre-school children aged 3-6 years, visiting a preschool, and the prevention of clinical ADHD symptoms. The 3-6 years old children will be identified by a combined parent and teacher rating ADHD-symptoms questionnaire (FBB-ADHS-V). Children with ADHD symptoms >90th percentile will participate in a following diagnostic process. The children (n = 150) will be randomised doubleblind to a control group (taking every day four capsules Equazen eye q, containing 400 mg fish oil and 100mg evening primrose oil - EPA (372mg), DHA (116mg), GLA (40mg) and vitamin E (7.2 mg) ) or placebo group. The study is divided into two phases with four months each. After unblinding after the first phase pre-school children taking placebo receive Omega-3/Omega-6 Fatty Acids. Children (n = 75) taking verum during first four months will be randomised doubleblind to verum or placebo. In this way the progress of the behaviour symptoms will be evaluated after a significant period of time (eigth months). Clinical examination (questionnaires, intelligence test, medical examination) and evaluation of ADHD symptoms through parents and teachers with several questionnaires will be used before beginning, after four months and after eight months. In addition the pre-school children will be taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. Additionally regular phone calls will be implemented. Medical examinations and meetings will taken place if required. If symptoms increase, children will be treated medical and/ or psychotherapeutically.
- Being tested
- omega-3/omega-6 fatty acids (PUFAs)
- Keywords
- omega-3/omega-6 fatty acids, Pre-school children with ADHD symptoms, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3/omega-6 fatty acids (PUFAs)Dietary supplement
Also called Equazen Eye Q
Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid
| Study group | Role | What they receive |
|---|---|---|
| omega-3/omega-6 fatty acids (PUFAs) | Experimental | Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid Receives: Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs) |
| placebo without PUFAs | Placebo comparator | Placebo without PUFAs Receives: Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers
The FBB-ADHS-V Questionnaire is a developed parent and teacher rating scale which assesses several factors of hyperactivity, impulsivity and inattention problems in pre-school or at home.
Measured: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Secondary outcomes (4)
Change in ODD symptoms -parent/ teacher rated (FBB-ADHD-V)
Measured: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
The CBCL and the TRF are well evaluated rating scales for the assessement of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively
Measured: Change from pre- assessment to post assessment four months after treatment begin.
Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV)
The DCL-ADHD and the DCL-ODD are external assessment questionnaires. Parents were asked 18 questions to hyperactivity, impulsivity and inattention by the rater or to symptom criteria for ODD.
Measured: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Change in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC)
The Kaufman Assessment Battery for Children (K-ABC) is a standardized test that assesses intelligence and achievement in children aged 2;6 to 12;6 years. It is comprised of four global test scores that include: sequential processing scales, simultaneous processing scales, achievement scales and mental processing composite. There is an additional nonverbal scale.
Measured: Change from pre- assessment to post assessment four months after treatment begin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startSep 2010
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
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 Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the StudyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Doepfner, University of Cologne
- Investigators
- Manfred Doepfner, Prof. Dr., Principal investigator, Department of Child and Adolescent Psychiatry Univ. Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795040
- Sponsor's protocol ID
- OMEGA-Study
- Status last verified
- Mar 2017
- First submitted
- 16 Feb 2013
- Last updated
- 16 Mar 2017
- 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 37058600
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD
- ClinicalTrials.gov ID
- NCT01795040
- Acronym / sponsor ID
- OMEGA-Study
- Keywords
- omega-3/omega-6 fatty acids, Pre-school children with ADHD symptoms, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 20 Feb 2013 (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 efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
Detailed description
The study aims at the reduction of hyperactivity, inattention and impulsivity in pre-school children aged 3-6 years, visiting a preschool, and the prevention of clinical ADHD symptoms. The 3-6 years old children will be identified by a combined parent and teacher rating ADHD-symptoms questionnaire (FBB-ADHS-V). Children with ADHD symptoms >90th percentile will participate in a following diagnostic process. The children (n = 150) will be randomised doubleblind to a control group (taking every day four capsules Equazen eye q, containing 400 mg fish oil and 100mg evening primrose oil - EPA (372mg), DHA (116mg), GLA (40mg) and vitamin E (7.2 mg) ) or placebo group. The study is divided into two phases with four months each. After unblinding after the first phase pre-school children taking placebo receive Omega-3/Omega-6 Fatty Acids. Children (n = 75) taking verum during first four months will be randomised doubleblind to verum or placebo. In this way the progress of the behaviour symptoms will be evaluated after a significant period of time (eigth months). Clinical examination (questionnaires, intelligence test, medical examination) and evaluation of ADHD symptoms through parents and teachers with several questionnaires will be used before beginning, after four months and after eight months. In addition the pre-school children will be taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. Additionally regular phone calls will be implemented. Medical examinations and meetings will taken place if required. If symptoms increase, children will be treated medical and/ or psychotherapeutically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3/omega-6 fatty acids (PUFAs) | Experimental | Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid |
| placebo without PUFAs | Placebo comparator | Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)Placebo without PUFAs |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 3 - 6 years
- Visit of a preschool (Kindergarten)
- Parents have a command of the German language
- Screening score >90th percentile in a combined parent and teacher screening questionnaire
Key exclusion criteria (3 listed)
- Hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine)
- Consumption of omega fatty acids preparation
- Consumption of fish oil-capsules
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/omega-6 fatty acids (PUFAs)Also: Equazen Eye QEquazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid | Dietary supplement | omega-3/omega-6 fatty acids (PUFAs), placebo without PUFAs |
Primary outcome
Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers
Time frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
The FBB-ADHS-V Questionnaire is a developed parent and teacher rating scale which assesses several factors of hyperactivity, impulsivity and inattention problems in pre-school or at home.
4 secondary outcomes
Change in ODD symptoms -parent/ teacher rated (FBB-ADHD-V)
Time frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
Time frame: Change from pre- assessment to post assessment four months after treatment begin.
Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV)
Time frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Change in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC)
Time frame: Change from pre- assessment to post assessment four months after treatment begin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- 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.
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.
Manfred Doepfner, Prof. Dr. contact
Manfred Doepfner, Prof. Dr. principal investigator
Department of Child and Adolescent Psychiatry Univ. Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3/omega-6 fatty acids (PUFAs) in people with Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study, run by University of Cologne at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 16 Mar 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manfred Doepfner, Prof. Dr. (Manfred.doepfner@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers (time frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin). 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 NCT01795040, 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 16 Mar 2017.