ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01055119
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Katharina Widenhorn-Mueller, University of Ulm

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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Dietary Supplement: Omega-3 fatty acids Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
Study Start Date : April 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Omega-3 fatty acids Dietary Supplement: Omega-3 fatty acids
duration: 4 month
Placebo Comparator: Olive oil Dietary Supplement: Omega-3 fatty acids
duration: 4 month



Primary Outcome Measures :
  1. Behavior, Cognition [ Time Frame: Before intervention and 16 weeks after start of intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055119


Locations
Germany
Klinik fuer Psychiatrie und Psychotherapie III
Ulm, Baden-Wuerttemberg, Germany, 89075
Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III
Ulm, Germany, D-89075
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Bode Harald, MD Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University

Responsible Party: Katharina Widenhorn-Mueller, Katharina Widenhorn-Mueller, PhD, University of Ulm
ClinicalTrials.gov Identifier: NCT01055119     History of Changes
Other Study ID Numbers: ADHD PUFA 2009
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms