Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Phase 4
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Dietary Supplement: Omega 3 caps
- Registration Number
- NCT00770627
- Lead Sponsor
- Laboratoires URGO
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo caps Omega 3 caps - Omega 3 caps Omega 3 caps -
- Primary Outcome Measures
Name Time Method ADHD rating scale 5 minutes
- Secondary Outcome Measures
Name Time Method Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity) 3 hours
Trial Locations
- Locations (2)
Clinical Investigation Center
🇫🇷Bron, France
Hopital Cardiovasculaire Louis Pradel
🇫🇷Bron, France