ADHD
Conditions
Keywords
ADHD, children, adolescents, Polyunsaturated Fatty Acids, ADHDRS - IV
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTω-3 fatty acids suspension
2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days
DIETARY_SUPPLEMENTplacebo suspension
suspension to mimic verum Esprico (R) suspension. 2 bags of Esprico(R) placebo suspension given orally once daily in the morning for 84 days
Sponsors
Engelhard Arzneimittel GmbH & Co.KG
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The verum nutrional supplementation is completely masked and an appropriate Placebo is provided. Up to know, none of the above mentioned is unblinded
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Written Informed Consent by parents and patients (separately for age groups 6 - 11 years and 12 - 17 years) * Children and adolescents of both gender in the age group between 6 and 17 years * Confirmed diagnosis of ADHD by semi-structured clinical interview Kiddie Schedule for Affective Disorders and Schizophrenia for school-age children (K-SADS) * ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored ≥24 * Sufficient knowledge of the German language
Exclusion criteria
* Known hypersensitivity against components of either the verum or placebo food * All serious internal diseases * All severe psychiatric diseases except oppositional defiant disorders * Current intake of the following medication: antidepressants and other psychotropic medication * Recent intake of ω-3 fatty acids supplementation * Indication for hospitalization * Suicidality (including suicidal thoughts) * intelligence quotient \< 70 * Previous medication with stimulants within 4 weeks * Placement in an institution on official or judicial ruling * Lack of willingness to store and transmit pseudonym data according to German regulations * Parallel participation in another trial, or less than 4 weeks ago * Patients foreseeable requiring a primary medication with methylphenidate during the study period of 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHDRS - IV | Difference in total score between baseline and end of study, an expected average of 84 days | The primary outcome measure for efficacy will be the absolute change in the ADHDRS total score between baseline and day 84 of randomized treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg-Depression Rating Scale (MADRS) | Baseline and each visit, monthly, an expected average of 84 days in total | Assessment of Symptoms of Depression. |
| Continuous Performance Test (CPT) | change from Baseline to end of treatment, an expected average of 84 days | Differences in Continuous Performance Test. |
| Barkley´s Side Effects Rating Scale | Baseline and each visit, monthly, an expected average of 84 days in total | Number of Participants with Adverse Events. |
| Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) | change from Baseline to end of treatment, an expected average of 84 days | Assessment of Symptoms of ADHD and to what degree individual's behavior or emotional problems have impacted various clinically relevant domains of functioning. |
| PUFA associated blood parameters | change from Baseline to end of treatment, an expected average of 84 days | complete fatty acid profile in red blood cells and relevant ratios, e.g. Omega-HS-Index, Plasma-Zinc, Plasma-Copper, Serum-Magnesium, Serum-Ferritin,... |
| Nutrition protocol | baseline | Assessment of diet habits. |
Countries
Germany
Outcome results
None listed