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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382616
First Posted: September 29, 2006
Last Update Posted: November 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00382616     History of Changes
Other Study ID Numbers: TASMC-03-NV-220-CTIL
First Submitted: September 28, 2006
First Posted: September 29, 2006
Last Update Posted: November 7, 2006
Last Verified: September 2006

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms