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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:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00382616
First received: September 28, 2006
Last updated: November 6, 2006
Last verified: September 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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 ClinicalTrials.gov Identifier (NCT Number):

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

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

ClinicalTrials.gov processed this record on June 17, 2013