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

Tel Aviv Sourasky Medical Center

Status and phase

Completed

Phase 2

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: Phosphatidylserine-Omega3

Study type

Interventional

Funder types

Other

Identifiers

NCT00382616

TASMC-03-NV-220-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

8 to 13 years old

Volunteers

No 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