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

Sponsored by:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00382616

Purpose

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.

Condition	Intervention	Phase
Attention-Deficit/Hyperactivity Disorder	Drug: Phosphatidylserine-Omega3	Phase II

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Studying the Effects of Phosphatidylserine Enriched With Omega-3 Fatty Acids on Symptoms of Attention-Deficit/Hyperactivity Disorder in Children

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	90
Study Start Date:	July 2004
Estimated Study Completion Date:	January 2005

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.

Eligibility

Ages Eligible for Study:	8 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382616

Locations

Israel
Clinical Nutrition Unit, Sourasky Medical Center
Tel Aviv, Israel, 64239

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:

Nachum Vaisman, MD

Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center

More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Vaisman N, Kaysar N, Zaruk-Adasha Y, Pelled D, Brichon G, Zwingelstein G, Bodennec J. Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids. Am J Clin Nutr. 2008 May;87(5):1170-80.

Study ID Numbers:	TASMC-03-NV-220-CTIL
Study First Received:	September 28, 2006
Last Updated:	November 6, 2006
ClinicalTrials.gov Identifier:	NCT00382616 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:

behavioral problems
learning problems
inattentive
impulsive
hyperactive
children
phosphatidylserine

long-chain polyunsaturated fatty acid
eicosapentaenoic acid
docosahexaenoic acid
omega3:omega6 ratio
eicosapentaenoic acid:arachidonic acid ratio
Test of Variables of Attention
ADHD index scores

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on May 07, 2009