Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder

NCT ID: NCT01055119

Last Updated: 2013-05-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-09-30

Brief Summary

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The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3 fatty acids

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

duration: 4 month

Olive oil

Group Type PLACEBO_COMPARATOR

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

duration: 4 month

Interventions

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Omega-3 fatty acids

duration: 4 month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* ADHD diagnosis
* Age 9-12y
* Native German speaker

Exclusion Criteria

* Allergy against fish and fish products
* IQ below 85
* Objections against pork gelatine
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Katharina Widenhorn-Mueller

Katharina Widenhorn-Mueller, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bode Harald, MD

Role: PRINCIPAL_INVESTIGATOR

Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University

Locations

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Klinik fuer Psychiatrie und Psychotherapie III

Ulm, Baden-Wurttemberg, Germany

Site Status

Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ADHD PUFA 2009

Identifier Type: -

Identifier Source: org_study_id

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