Supplementation of Phosphatidylserine (PS) and n-3 Long Chain Fatty Acids (EPA, DHA) in Children With ADHD

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

Studying the Effects of Phosphatidylserine Enriched With Omega-3 Fatty Acids on Symptoms of Attention-Deficit/Hyperactivity Disorder in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382616
• Other study ID #: TASMC-03-NV-220-CTIL
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2006
• Last updated: November 6, 2006
• Start date: July 2004
• Est. completion date: January 2005

Study information

• Verified date: September 2006
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect Attention-deficit/hyperactivity disorder symptoms in children.

Description:

BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) encompasses a broad constellation of behavioral and learning problems, clinically describes inattentive, impulsive, and/or hyperactive children. These patients are characterized by low blood LC-PUFA (LC-PUFA) levels; however the LC-PUFA supplementation effect on ADHD symptoms is not clear.

METHODS Eighty-three ADHD children (3:1 boys:girls), 8-13 years old, were assigned in a randomized, double-blind, placebo-controlled parallel design to receive 250 mg/d of eicosapentaenoic acid + docosahexaenoic acid provided as phosphatidylserine (300 mg/d PS-Omega3), or fish oil or placebo for 3 months. Stimulant medication or other dietary supplements were prohibited. The measured outcomes were inattention and impulsivity, evaluated by Test of Variables of Attention (TOVA) and blood lipids profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

• 8 and 13 years of age; diagnosed as having ADHD; otherwise healthy;

Exclusion Criteria:

• significant sensory or neurological limitations, epilepsy, mental retardation, psychosis, or pervasive developmental disorder; medications with known central nervous system effects such as tranquilizers, antidepressants, stimulants (including methylphenidate and amphetamines), sedating antihistamines and some asthma medications and dietary supplements but vitamins

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Phosphatidylserine-Omega3

Locations

Country	Name	City	State
Israel	Clinical Nutrition Unit, Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)
Primary	Blood lipids profile
Secondary	Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form
Secondary	Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach