- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055119
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder (EFA)
May 2, 2013 updated by: Katharina Widenhorn-Mueller, University of Ulm
Effect of Supplementation With Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder
The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ulm, Germany, D-89075
- Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III
-
-
Baden-Wuerttemberg
-
Ulm, Baden-Wuerttemberg, Germany, 89075
- Klinik fuer Psychiatrie und Psychotherapie III
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Omega-3 fatty acids
|
duration: 4 month
|
PLACEBO_COMPARATOR: Olive oil
|
duration: 4 month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavior, Cognition
Time Frame: Before intervention and 16 weeks after start of intervention
|
Before intervention and 16 weeks after start of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bode Harald, MD, Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (ACTUAL)
September 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
January 22, 2010
First Submitted That Met QC Criteria
January 22, 2010
First Posted (ESTIMATE)
January 25, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADHD PUFA 2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Hyperactivity Disorder
-
Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
-
Cingulate TherapeuticsPremier Research Group plcActive, not recruitingADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
-
Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
-
University Hospital Bispebjerg and FrederiksbergMental Health Services in the Capital Region, DenmarkRecruitingSleep Disturbance | Neurodevelopmental Disorders | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder | Attention-Deficit Hyperactivity Disorder, Unspecified Type | Attention-deficit Hyperactivity | Hyperkinetic Conduct DisorderDenmark
-
Corium, Inc.Worldwide Clinical Trials; Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Corium, Inc.Premier Research Group plc; Almac; Prometrika, LLCActive, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Massachusetts General HospitalShire Human Genetic Therapies, Inc.Active, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Ataturk UniversityCompletedAttention-deficit/Hyperactivity DisorderTurkey
Clinical Trials on Omega-3 fatty acids
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBreast Neoplasms | ArthralgiaUnited States
-
S.LAB (SOLOWAYS)Center of New Medical Technologies; Triangel ScientificCompletedLDL Hyperlipoproteinemia | Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia | Triglyceride Storage Type I or II DiseaseRussian Federation
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsCompleted
-
Wen-Chih WuWithdrawnSteatosis | Right Ventricular Failure | Pulmonary; HypertensionUnited States
-
University of California, San FranciscoAutism SpeaksCompleted
-
Pennington Biomedical Research CenterCompleted
-
Evandro Chagas Institute of Clinical ResearchAndrea Silvestre de Sousa, MD PhD; Pedro Emmanuel Alvarenga Americano do Brasil... and other collaboratorsCompletedChagas CardiomyopathyBrazil
-
Hugo W. Moser Research Institute at Kennedy Krieger...University of California, San FranciscoCompletedAutism Spectrum Disorders | HyperactivityUnited States
-
Retina Foundation of the SouthwestDSM Nutritional Products, Inc.CompletedInfant DevelopmentUnited States
-
Centre for Chronic Disease Control, IndiaCompleted