A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

Laboratoires URGO2 sites in 1 country160 target enrollmentOctober 2008

ConditionsAttention Deficit Hyperactivity Disorder

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Laboratoires URGO
Enrollment: 160
Locations: 2
Primary Endpoint: ADHD rating scale
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.

The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

December 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratoires URGO

Eligibility Criteria

Inclusion Criteria

•6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent

Exclusion Criteria

•Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week