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:
Laboratoires URGO
Information provided by:
Laboratoires URGO
ClinicalTrials.gov Identifier:
NCT00770627
First received: October 9, 2008
Last updated: April 12, 2010
Last verified: April 2010
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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 (Child) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| 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:
|
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 26, 2016