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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katharina Widenhorn-Mueller, University of Ulm
ClinicalTrials.gov Identifier:
NCT01055119
First received: January 22, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Attention Deficit Hyperactivity Disorder
Dietary Supplement: Omega-3 fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Behavior, Cognition [ Time Frame: Before intervention and 16 weeks after start of intervention ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 22, 2010
Last Updated: May 2, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014