Attention-Deficit/Hyperactivity Disorder Clinical Trial
Official title:
Studying the Effects of Phosphatidylserine Enriched With Omega-3 Fatty Acids on Symptoms of Attention-Deficit/Hyperactivity Disorder in Children
Verified date | September 2006 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | January 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 13 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Clinical Nutrition Unit, Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA) | |||
Primary | Blood lipids profile | |||
Secondary | Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form | |||
Secondary | Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach |
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