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

NCT ID: NCT01340690

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-08

Study Completion Date

2017-03-01

Brief Summary

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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

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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.

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The verum "nutrional supplementation" is completely masked and an appropriate Placebo is provided. Up to know, none of the above mentioned is unblinded

Study Groups

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ω-3 fatty acids suspension

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)

Group Type ACTIVE_COMPARATOR

ω-3 fatty acids suspension

Intervention Type DIETARY_SUPPLEMENT

2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days

placebo suspension

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.

Group Type PLACEBO_COMPARATOR

placebo suspension

Intervention Type 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

Interventions

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ω-3 fatty acids suspension

2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Esprico(R) suspension 2 verum to 1 placebo

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Engelhard Arzneimittel GmbH & Co.KG

INDUSTRY

Sponsor Role collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Prof. Huss

Michael Huss, Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Huss, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry

Locations

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DRK Fachklinik für Kinder- und Jugendpsychiatrie, Psychotherapie, Psychosomatik

Bad Neuenahr, , Germany

Site Status

Charité - Universitätsmedizin Berlin, CVK Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

Berlin, , Germany

Site Status

University Medicine Mainz

Mainz, , Germany

Site Status

Kinderzentrum Maulbronn gGmbH

Maulbronn, , Germany

Site Status

Johanniter - Zentrum für Kinder- und Jugendpsychiatrie Neuwied

Neuwied, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19672626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20868469 (View on PubMed)

Other Identifiers

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PAD-EA-10-01-067

Identifier Type: -

Identifier Source: org_study_id