Supplementation of Phosphatidylserine (PS) and n-3 Long Chain Fatty Acids (EPA, DHA) in Children With ADHD
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Studying the Effects of Phosphatidylserine Enriched With Omega-3 Fatty Acids on Symptoms of Attention-Deficit/Hyperactivity Disorder in Children|
- Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)
- Blood lipids profile
- Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form
- Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||January 2005|
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.
|Clinical Nutrition Unit, Sourasky Medical Center|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Nachum Vaisman, MD||Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center|