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

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ClinicalTrials.gov Identifier: NCT00770627
Recruitment Status : Unknown
Verified April 2010 by Laboratoires URGO.
Recruitment status was:  Enrolling by invitation
First Posted : October 10, 2008
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Dietary Supplement: Omega 3 caps Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo caps 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
Active Comparator: Omega 3 caps 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



Primary Outcome Measures :
  1. ADHD rating scale [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity) [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770627


Locations
France
Clinical Investigation Center
Bron, France, 69677
Hopital Cardiovasculaire Louis Pradel
Bron, France, 69677
Sponsors and Collaborators
Laboratoires URGO

Responsible Party: Doctor Olivier Revol, Pierre Wertheimer Hospital
ClinicalTrials.gov Identifier: NCT00770627     History of Changes
Other Study ID Numbers: F-08-08-3103039
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010

Keywords provided by Laboratoires URGO:
160 children
parallel group

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders