Not provided
Not provided
Not provided
Not provided
The sample size of the planned interims analysis was achieved
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Engelhard Arzneimittel GmbH & Co.KG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine the nutritional efficacy of Polyunsaturated Fatty Acids (PUFAs) in combination with zinc and magnesium, in children and adolescents diagnosed with Attention Deficit/ Hyperactivity Disorder (ADHD). The nutritional efficacy has to be proven in agreement with the German "Verordnung über Diätetische Lebensmittel (DiätV)" and the corresponding European Directive 1999/21/EC. This objective is reached by performing a placebo-controlled supplementation study with a main efficacy criterion which is also being used in pivotal studies of stimulant and non-stimulant drugs, i.e. the treatment differences between final visit and baseline in the Attention Deficit Hyperactivity Disorder Rating Scale, Parent Version IV (ADHDRS-IV).
The syndrome of ADHD affects 5-6% of the children and adolescents worldwide. The hallmarks are inattention, impulsivity and hyperactivity. Due to parent's fear of significant adverse effects caused by stimulant or non-stimulant therapy a high degree of children with ADHD remains untreated. Recent observational studies showed that ADHD is often associated with decreased nutritional status of certain PUFAs, zinc and magnesium which might be due to metabolic disturbances in the case of fatty acids. First interventional studies revealed that a supplementation of these nutrients may affect ADHD-related disorders and might improve certain clinical parameters, such as concentration.
Participants will be randomly assigned to receive either a nutritional supplement or placebo once a day for the duration of 84 days. Participants will come in for the assessment of ADHD symptoms, compliance and the assessment of secondary outcome variables. Side effects will be monitored continuously and also assessed by rating scales.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ω-3 fatty acids suspension | Active Comparator | 2 bags of Esprico(R) suspension each day. Each 4ml suspension bag includes 400mg eicosapentaenoic acid (EPA), 40mg docosahexaenoic acid (DHA), 5.4 mg gamma-linolenic acid (GLA), 80 mg magnesium, 5 mg zinc and consists of linseed oil, xylitol, sea fish oil with high portion of omega-3-acids, magnesium citrate, vegetable oil, orange flavour, evening primrose oil, zink gluconate, soya lecithin, citric acid, acesulfame k (E950) |
|
| placebo suspension | Placebo Comparator | 2 bags of Esprico (R) placebo suspension. Includes no ω-3 fatty acids, no ω-6 fatty acids, no magnesium and no zinc, but other vegetable oils, orange flavor, etc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ω-3 fatty acids suspension | Dietary Supplement | 2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHDRS - IV | The primary outcome measure for efficacy will be the absolute change in the ADHDRS total score between baseline and day 84 of randomized treatment. | Difference in total score between baseline and end of study, an expected average of 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Barkley´s Side Effects Rating Scale | Number of Participants with Adverse Events. | Baseline and each visit, monthly, an expected average of 84 days in total |
| Montgomery-Åsberg-Depression Rating Scale (MADRS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Huss, Prof. Dr. | University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik | Bad Neuenahr | D 53474 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19672626 | Background | Schuchardt JP, Huss M, Stauss-Grabo M, Hahn A. Significance of long-chain polyunsaturated fatty acids (PUFAs) for the development and behaviour of children. Eur J Pediatr. 2010 Feb;169(2):149-64. doi: 10.1007/s00431-009-1035-8. Epub 2009 Aug 12. | |
| 20868469 | Background | Huss M, Volp A, Stauss-Grabo M. Supplementation of polyunsaturated fatty acids, magnesium and zinc in children seeking medical advice for attention-deficit/hyperactivity problems - an observational cohort study. Lipids Health Dis. 2010 Sep 24;9:105. doi: 10.1186/1476-511X-9-105. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We use the dietary supplementation like a medication and performed the study like a phase 3 medication study, because the dietary supplementation (verum) is available as special preparation in drug stores.
Not provided
Not provided
The verum "nutrional supplementation" is completely masked and an appropriate Placebo is provided. Up to know, none of the above mentioned is unblinded
| placebo suspension | Dietary Supplement | suspension to mimic verum Esprico (R) suspension. 2 bags of Esprico(R) placebo suspension given orally once daily in the morning for 84 days |
|
Assessment of Symptoms of Depression.
| Baseline and each visit, monthly, an expected average of 84 days in total |
| Continuous Performance Test (CPT) | Differences in Continuous Performance Test. | change from Baseline to end of treatment, an expected average of 84 days |
| Nutrition protocol | Assessment of diet habits. | baseline |
| Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) | Assessment of Symptoms of ADHD and to what degree individual's behavior or emotional problems have impacted various clinically relevant domains of functioning. | change from Baseline to end of treatment, an expected average of 84 days |
| PUFA associated blood parameters | complete fatty acid profile in red blood cells and relevant ratios, e.g. Omega-HS-Index, Plasma-Zinc, Plasma-Copper, Serum-Magnesium, Serum-Ferritin,... | change from Baseline to end of treatment, an expected average of 84 days |
| Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters |
| Berlin |
| D 13353 |
| Germany |
| University Medicine Mainz | Mainz | D 55131 | Germany |
| Kinderzentrum Maulbronn gGmbH | Maulbronn | D 75433 | Germany |
| Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied | Neuwied | D 56564 | Germany |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided