Clinical trial NCT00382616: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-09-29
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)
measure: Blood lipids profile
Secondary outcomes:
measure: Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form
measure: Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clinical Nutrition Unit, Sourasky Medical Center
Study officials:
affiliation: Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center
name: Nachum Vaisman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.