PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children

Phase 2

• Conditions: ADHD
• Interventions: Dietary Supplement: PS-Omega3 conjugate supplementation; Dietary Supplement: placebo

• Registration Number: NCT00700323
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Last Update Submitted: 2008-06-17
• Study First Posted: 2008-06-18
• Last Update Posted: 2008-06-18
• Study Start: 2008-07
• Primary Completion: 2009-07
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Parental written informed consent.
2. Age: 13≥ years ≥8 (including).
3. Gender: both male and female.
4. TOVA computerized test score ≤-1.8 at baseline.
5. Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
6. Normal weight and height according to Israeli standards.
7. 21 days without any treatment for ADHD symptoms, whether medication or food supplement.

Exclusion Criteria

1. History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
2. Pervasive developmental disorder or Non-Verbal Learning Disability
3. Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
4. 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.
5. Having a sibling already included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PS-Omega3 conjugate supplementation	Patients receiving active product
2	placebo	Patients receiving placebo

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel