Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00770627
• Other study ID #: F-08-08-3103039
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: April 12, 2010
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Laboratoires URGO
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Dietary Supplement:
• Omega 3 caps
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

Locations

Country	Name	City	State
France	Clinical Investigation Center	Bron
France	Hopital Cardiovasculaire Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD rating scale		5 minutes	No
Secondary	Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)		3 hours	No