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

September 28, 2006
November 6, 2006
July 2004
Not Provided
  • Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)
  • Blood lipids profile
Same as current
Complete list of historical versions of study NCT00382616 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Supplementation of Phosphatidylserine (PS) and n-3 Long Chain Fatty Acids (EPA, DHA) in Children With ADHD
Studying the Effects of Phosphatidylserine Enriched With Omega-3 Fatty Acids on Symptoms of Attention-Deficit/Hyperactivity Disorder in Children

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention-Deficit/Hyperactivity Disorder
Drug: Phosphatidylserine-Omega3
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
January 2005
Not Provided

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
Both
8 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00382616
TASMC-03-NV-220-CTIL
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Nachum Vaisman, MD Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center
Tel-Aviv Sourasky Medical Center
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP