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

Phase 2

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder

• Registration Number: NCT00382616
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-07
• Study Completion: 2005-01
• Status Verified: 2006-09
• Study First Submitted: 2006-09-28
• Study First Submitted QC: 2006-09-28
• Study First Posted: 2006-09-29
• Last Update Submitted: 2006-11-06
• Last Update Posted: 2006-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)
Blood lipids profile

Secondary Outcome Measures

Name	Time	Method
Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach
Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form

Trial Locations

Locations (1)

Clinical Nutrition Unit, Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel