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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Laboratoires URGO
ClinicalTrials.gov Identifier:
NCT00770627
First received: October 9, 2008
Last updated: April 12, 2010
Last verified: April 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:


Further study details as provided by Laboratoires URGO:

Primary Outcome Measures:
  • ADHD rating scale [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770627

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

No publications provided

Responsible Party: Doctor Olivier Revol, Pierre Wertheimer Hospital
ClinicalTrials.gov Identifier: NCT00770627     History of Changes
Other Study ID Numbers: F-08-08-3103039
Study First Received: October 9, 2008
Last Updated: April 12, 2010
Health Authority: France: Ministry of Health

Keywords provided by Laboratoires URGO:
160 children
parallel group

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014