ADHDPhase 1/2NCT02114632
Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 1/2 study testing Eye Q in people with ADHD, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy boys. Read more about this study
- Who is it for?
- Ages 8 to 16 years, men only
- Conditions the study is for
- ADHD
- What is being tested?
- Eye Q
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2007to May 2012
- Phase
- Phase 1/2
- 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 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Patients will be boys between the ages of 8-16 years.
- Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
- Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
- Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment
Who cannot join
- Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
- Patients with a history of epilepsy
- Patients with a history of asthma treated with corticosteroids.
- Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
- Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
- Patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).
Trial locations and contacts
1 site in 1 country.
Poland1 site
Child and Adolescent Psychiatry Department, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 00-576
About this study
Official title: A Double Blind, Placebo Controlled Trial of Effectiveness of Omega-3 and Omega-6 Polyunsaturated Fatty Acids in Treatment of Children With Attention Deficit/Hyperactivity Disorder
The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy boys.
Read the detailed description
The study is designed as a randomized, double-blind placebo-controlled trial with a total duration of 6 months. 100-120 boys with ADHD aged 8-16 years and 30 healthy boys will will be randomized to 3 months of treatment with a fixed dose of 6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg eicosapentaenoic acid (EPA), 174 mg docosahexaenoic acid (DHA), 60 mg gamma-linolenic acid (GLA) per day) or to placebo (olive oil). At 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive active treatment for the remaining 3 month period. Control group will receive active treatment for 6 month. The assessment of children will be made 3 times: at the point of start, after 3 months, and after 6 months. The assessments will be made using standardized interviews and questionnaires, neuropsychological tests, pediatric and neurological examination and taking a 5 ml sample of blood to assess level of polyunsaturated fatty acids (PUFA) in serum and in cell membranes of erythrocytes.
- Conditions
- ADHD
- Being tested
- Eye Q
- Keywords
- ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA
- 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.
Eye QDietary supplement
3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period.
| Study group | Role | What they receive |
|---|---|---|
| Polyunsaturated fatty acids | Active comparator | 6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg EPA, 174 mg DHA, 60 mg GLA per day) Receives: Dietary Supplement: Eye Q |
| placebo | Placebo comparator | 6 capsules of olive oil per day divided in two daily doses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention
Measured: change from baseline at 6 months
Secondary outcomes (1)
assessment of adverse events.
Measured: change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJan 2007
- Primary completionMay 2012
- Study completionMay 2012
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 ADHDStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Grygo, Medical University of Warsaw
- Investigators
- Magdalena Grygo, MD, Principal investigator, Medical University of Warsaw, Child and Adolescent Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114632
- Sponsor's protocol ID
- KB/154/2006
- Status last verified
- Apr 2014
- First submitted
- 23 Mar 2014
- Last updated
- 15 Apr 2014
- 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 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Trial of Effectiveness of Omega-3 and Omega-6 Polyunsaturated Fatty Acids in Treatment of Children With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02114632
- Acronym / sponsor ID
- KB/154/2006
- Conditions
- ADHD
- Keywords
- ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Apr 2014 (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 purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy boys.
Detailed description
The study is designed as a randomized, double-blind placebo-controlled trial with a total duration of 6 months. 100-120 boys with ADHD aged 8-16 years and 30 healthy boys will will be randomized to 3 months of treatment with a fixed dose of 6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg eicosapentaenoic acid (EPA), 174 mg docosahexaenoic acid (DHA), 60 mg gamma-linolenic acid (GLA) per day) or to placebo (olive oil). At 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive active treatment for the remaining 3 month period. Control group will receive active treatment for 6 month. The assessment of children will be made 3 times: at the point of start, after 3 months, and after 6 months. The assessments will be made using standardized interviews and questionnaires, neuropsychological tests, pediatric and neurological examination and taking a 5 ml sample of blood to assess level of polyunsaturated fatty acids (PUFA) in serum and in cell membranes of erythrocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyunsaturated fatty acids | Active comparator | Dietary Supplement: Eye Q6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg EPA, 174 mg DHA, 60 mg GLA per day) |
| placebo | Placebo comparator | –6 capsules of olive oil per day divided in two daily doses. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients will be boys between the ages of 8-16 years.
- Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
- Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
- Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment
Key exclusion criteria (6 listed)
- Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
- Patients with a history of epilepsy
- Patients with a history of asthma treated with corticosteroids.
- Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
- Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
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 |
|---|---|---|
| Eye Q3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period. | Dietary supplement | Polyunsaturated fatty acids |
Primary outcome
assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention
Time frame: change from baseline at 6 months
1 secondary outcome
assessment of adverse events.
Time frame: change from baseline at 6 months
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 Apr 2014.
- 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.
Magdalena Grygo, MD principal investigator
Medical University of Warsaw, Child and Adolescent Psychiatry Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eye Q in people with ADHD, run by Medical University of Warsaw at 1 site in Poland.
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 6 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 Apr 2014. 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 Poland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention (time frame: change from baseline at 6 months). 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 NCT02114632, 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 Apr 2014.