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

ADHD Clinical Trial

— ADHD-3  

Official title:

Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00700323
• Other study ID #: TASMC-08-NV-263
• Secondary ID: 263-08-TLV
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: June 17, 2008
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, Prof'
• Phone: 972-3-697-4807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Dietary Supplement:
• PS-Omega3 conjugate supplementation

• placebo

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Enzymotec

Country where clinical trial is conducted

Israel,