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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2010 by Laboratoires URGO.
Recruitment status was: Enrolling by invitation

Sponsor:

ClinicalTrials.gov Identifier:

NCT00770627

First Posted: October 10, 2008

Last Update Posted: April 13, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Laboratoires URGO

Purpose

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	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Dietary Supplement: Omega 3 caps	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Laboratoires URGO:

Primary Outcome Measures:

ADHD rating scale [ Time Frame: 5 minutes ]

Secondary Outcome Measures:

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


Estimated Enrollment:	160
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Contacts and Locations

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

More Information


Responsible Party:	Doctor Olivier Revol, Pierre Wertheimer Hospital
ClinicalTrials.gov Identifier:	NCT00770627 History of Changes
Other Study ID Numbers:	F-08-08-3103039
First Submitted:	October 9, 2008
First Posted:	October 10, 2008
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

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