This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
231
Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
Centro Médico Teknon
Barcelona, Spain
Improvement in clinical symptoms of ADHD
Differences between groups measured by: 1. Number of criteria of the ADHD-Scale-IV rated by parents and teachers 2. Clinical Global Impressions Scale (CGI) assessed by the physician
Time frame: At baseline and at 6 months
Changes in neuropsychological outcomes
Differences between groups measured by Scores of the Conners Continuous Performance Test-II (CPT-II) which evaluate potential problems related to executive functions perception, internal ordering, working memory, motor control.
Time frame: At baseline and at 6 months
Changes in emotional outcomes
Differences between groups measured by Cognitive Assessment System (CAS) for children between 6-8 years old and by State-Trait Anxiety Inventory for Children (STAIC) for children between 9-12 years old.
Time frame: At baseline and at 6 months
Changes in Children's Quality of Life
Differences between groups measured with Child Health and Illness Profile- Parent Form (CHIP-CE)
Time frame: At baseline and at 6 months
Changes in Quality of Life of Parents of Children with ADHD
Differences between groups measured with a Short Version of the World Health Organization Quality of Life Instruments (WHOQoL)
Time frame: At baseline and at 6 months
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