Attention-Deficit/Hyperactivity Disorder
Conditions
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
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.
Interventions
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood lipids profile | — |
| Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Israel
Outcome results
None listed