Back to resultsEffect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder (EFA)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
About this trial
This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- Klinik fuer Psychiatrie und Psychotherapie III
- Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omega-3 fatty acids
Olive oil
Arm Description
Outcomes
Primary Outcome Measures
Behavior, Cognition
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01055119
Brief Title
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
Acronym
EFA
Official Title
Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 fatty acids
Arm Type
Active Comparator
Arm Title
Olive oil
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
duration: 4 month
Primary Outcome Measure Information:
Title
Behavior, Cognition
Time Frame
Before intervention and 16 weeks after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bode Harald, MD
Organizational Affiliation
Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik fuer Psychiatrie und Psychotherapie III
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III
City
Ulm
ZIP/Postal Code
D-89075
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
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