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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Attention-Deficit/Hyperactivity Disorder

Keywords

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Phosphatidylserine-Omega3

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Nachum Vaisman, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center

Locations

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Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED

PMID: 18469236 (View on PubMed)

Other Identifiers

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TASMC-03-NV-220-CTIL

Identifier Type: -

Identifier Source: org_study_id