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

NCT01340690 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2017-09-20

No results posted yet for this study

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).

Conditions

  • ADHD

Interventions

DIETARY_SUPPLEMENT

ω-3 fatty acids suspension

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

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

Sponsors & Collaborators

  • Engelhard Arzneimittel GmbH & Co.KG

    collaborator INDUSTRY

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Michael Huss, Prof. Dr. · University Medicine, Mainz, Dep. of Child and Adolescent Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-08
Primary Completion
2016-03-31
Completion
2017-03-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340690 on ClinicalTrials.gov