Status:
UNKNOWN
PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Enzymotec
Conditions:
ADHD
Eligibility:
All Genders
8-13 years
Phase:
PHASE2
Brief Summary
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.
Eligibility Criteria
Inclusion
- Parental written informed consent.
- Age: 13≥ years ≥8 (including).
- Gender: both male and female.
- TOVA computerized test score ≤-1.8 at baseline.
- Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
- Normal weight and height according to Israeli standards.
- 21 days without any treatment for ADHD symptoms, whether medication or food supplement.
Exclusion
- History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
- Pervasive developmental disorder or Non-Verbal Learning Disability
- Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
- History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
- Having a sibling already included in the study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00700323
Start Date
July 1 2008
End Date
July 1 2009
Last Update
June 18 2008
Active Locations (1)
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1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel