Back to resultsClinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Omega 3 caps
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring 160 children, parallel group
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
Sites / Locations
- Clinical Investigation Center
- Hopital Cardiovasculaire Louis Pradel
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo caps
Omega 3 caps
Arm Description
Outcomes
Primary Outcome Measures
ADHD rating scale
Secondary Outcome Measures
Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770627
Brief Title
Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Official Title
A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires URGO
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
160 children, parallel group
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo caps
Arm Type
Placebo Comparator
Arm Title
Omega 3 caps
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 caps
Intervention Description
Children between 6 and 8 years must take 2 caps/day Children between 9 and 11 years must take 3 caps/day Children between 12 and 15 years must take 4 caps /day
Primary Outcome Measure Information:
Title
ADHD rating scale
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Investigation Center
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Cardiovasculaire Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
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