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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Phosphatidylserine-Omega3

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring 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

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Nutrition Unit, Sourasky Medical Center

Outcomes

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

Full Information

NCT ID

NCT00382616

First Posted

September 28, 2006

Last Updated

November 6, 2006

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00382616

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention-Deficit/Hyperactivity Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Phosphatidylserine-Omega3

Primary Outcome Measure Information:

Title

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

Title

Blood lipids profile

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nachum Vaisman, MD

Organizational Affiliation

Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Nutrition Unit, Sourasky Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

18469236

Citation

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. doi: 10.1093/ajcn/87.5.1170.

Results Reference

derived

Learn more about this trial

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

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