Epilepsy Clinical Trial
Official title:
Efficacy of Phosphatidylserine Enriched With Polyunsaturated n-3 Fatty Acid Supplementation on Attention Deficit Disorders in Children With Epilepsy. A Randomized Double-blind Placebo-controlled Trial
Our project aims to develop a new therapeutic approach in epilepsy-associated attention
disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids,
containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a
phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA
supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children
with epilepsy. Secondary objectives include:
- To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.
- To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid
profiles.
- To assess the tolerance of a supplementation of PS-Omega 3.
- To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.
- To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,
1. on attention disorders in children with epilepsy,
2. on quality of life,
3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects
aged 6- 16 years, suffering from epilepsy (any type) and attention deficit
hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V
criteria in 12 clinical sites in France.
n/a
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