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
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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 |

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
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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
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- ADHD rating scale [ Time Frame: 5 minutes ]
- Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity) [ Time Frame: 3 hours ]

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

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
France | |
Clinical Investigation Center | |
Bron, France, 69677 | |
Hopital Cardiovasculaire Louis Pradel | |
Bron, France, 69677 |
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 |