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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| placebo | Placebo Comparator | 6 capsules of olive oil per day divided in two daily doses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Q | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention | change from baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of adverse events. | change from baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of connection between level of fatty acids in serum and intensity of ADHD symptoms in treated group according to placebo intervention | change from baseline at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magdalena Grygo, MD | Medical University of Warsaw, Child and Adolescent Psychiatry Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and Adolescent Psychiatry Department, Medical University of Warsaw | Warsaw | Masovian Voivodeship | 00-576 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37058600 | Derived | 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. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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