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

Attention Deficit Hyperactivity Disorder Clinical Trial

— EFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055119
• Other study ID #: ADHD PUFA 2009
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: May 2, 2013
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• Omega-3 fatty acids
duration: 4 month

Locations

Country	Name	City	State
Germany	Klinik fuer Psychiatrie und Psychotherapie III	Ulm	Baden-Wuerttemberg
Germany	Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior, Cognition		Before intervention and 16 weeks after start of intervention	No