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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382616
|Clinical Nutrition Unit, Sourasky Medical Center|
|Tel Aviv, Israel, 64239|
|Principal Investigator:||Nachum Vaisman, MD||Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center|