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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
284
2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days
suspension to mimic verum Esprico (R) suspension. 2 bags of Esprico(R) placebo suspension given orally once daily in the morning for 84 days
DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik
Bad Neuenahr, Germany
Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Berlin, Germany
University Medicine Mainz
Mainz, Germany
Kinderzentrum Maulbronn gGmbH
Maulbronn, Germany
Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied
Neuwied, Germany
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.
Time frame: Difference in total score between baseline and end of study, an expected average of 84 days
Barkley´s Side Effects Rating Scale
Number of Participants with Adverse Events.
Time frame: Baseline and each visit, monthly, an expected average of 84 days in total
Montgomery-Åsberg-Depression Rating Scale (MADRS)
Assessment of Symptoms of Depression.
Time frame: Baseline and each visit, monthly, an expected average of 84 days in total
Continuous Performance Test (CPT)
Differences in Continuous Performance Test.
Time frame: change from Baseline to end of treatment, an expected average of 84 days
Nutrition protocol
Assessment of diet habits.
Time frame: 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.
Time frame: 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,...
Time frame: change from Baseline to end of treatment, an expected average of 84 days
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