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Completed

NCT Number: NCT00382616

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Child Behavior Impulsive Behavior Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Problem Behavior Signs and Symptoms Spasm

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, 64239, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phosphatidylserine-Omega3

Drug

Primary outcomes

  1. Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)

  2. Blood lipids profile

Secondary outcomes

  1. Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form

  2. Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 29, 2006
Registry last updated
Nov 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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