Efficacy Study of Polyunsaturated Fatty Acids in Children and Adolescents With Attention Deficit/ Hyperactivity Disorder

ADHD Clinical Trial

— PAD  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01340690
• Other study ID #: PAD-EA-10-01-067
• Status: Terminated
• Phase: Phase 3
• First received: April 7, 2011
• Last updated: September 19, 2017
• Start date: March 8, 2011
• Est. completion date: March 1, 2017

Study information

• Verified date: September 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 284
• Est. completion date: March 1, 2017
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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 ?-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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Dietary Supplement:
• ?-3 fatty acids suspension
2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days
• placebo 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

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Engelhard Arzneimittel GmbH & Co.KG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Huss M, Völp 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Montgomery-Åsberg-Depression Rating Scale (MADRS)	Assessment of Symptoms of Depression.	Baseline and each visit, monthly, an expected average of 84 days in total
Secondary	Continuous Performance Test (CPT)	Differences in Continuous Performance Test.	change from Baseline to end of treatment, an expected average of 84 days
Secondary	Nutrition protocol	Assessment of diet habits.	baseline
Secondary	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
Secondary	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