Clinical trial NCT01340690: Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder
Official title: PAD-study: Nutritional Efficacy of Polyunsaturated Fatty Acids (Omega-3 and Omega-6) in Combination With Zinc and Magnesium Versus Placebo in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: ADHD
Keywords: ADHD
children
adolescents
Polyunsaturated Fatty Acids
ADHDRS - IV
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Engelhard Arzneimittel GmbH & Co.KG
First posted: 2011-04-22
Enrollment: 284
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHDRS - IV
timeFrame: Difference in total score between baseline and end of study, an expected average of 84 days
Secondary outcomes:
measure: Barkley´s Side Effects Rating Scale
timeFrame: Baseline and each visit, monthly, an expected average of 84 days in total
measure: Montgomery-Åsberg-Depression Rating Scale (MADRS)
timeFrame: Baseline and each visit, monthly, an expected average of 84 days in total
measure: Continuous Performance Test (CPT)
timeFrame: change from Baseline to end of treatment, an expected average of 84 days
measure: Nutrition protocol
timeFrame: baseline
measure: Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
timeFrame: change from Baseline to end of treatment, an expected average of 84 days
measure: PUFA associated blood parameters
timeFrame: change from Baseline to end of treatment, an expected average of 84 days
Other outcomes:
Locations:
city: Bad Neuenahr
country: Germany
facility: DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
city: Mainz
country: Germany
facility: University Medicine Mainz
city: Maulbronn
country: Germany
facility: Kinderzentrum Maulbronn gGmbH
city: Neuwied
country: Germany
facility: Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied
Study officials:
affiliation: University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry
name: Michael Huss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.