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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 13
- 主要终点
- Reduction of the ADHD-rating scale IV inattentive subscore in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment.
研究概览
简要总结
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,
- on attention disorders in children with epilepsy,
- on quality of life,
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 15 years and 11 months.
- •Children of either sex (male/female) suffering from epilepsy regardless of syndrome classification.
- •Subjects on a stable dose of antiepileptic drugs (AED) for at least one month prior to inclusion and subjects for whom no change is considered a priori for the three months following the inclusion.
- •Diagnosis of ADHD inattention or mixed type according to the DSM V criteria.
- •Subjects must agree to study participation and their parents/legal guardian must provide written inform consent prior to participation in the study.
排除标准
- •Subjects less than 6 years or older than 16 years old
- •AED not stable for at least one month and/or a change in AED is expected in the three months following inclusion.
- •Diagnosis of ADHD hyperactivity type exclusive according to DSM V criteria.
- •Mental retardation defined by a score < 70 on the verbal comprehension and perceptual reasoning Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), performed within 18 months prior to inclusion or at V
- •Diagnosis of a psychiatric comorbidity other than ADHD according to the DSM V criteria, including: pervasive developmental disorders including autism disorders; bipolar disordersand psychotic disorders.
- •Children suffering from diabetes, any type.
- •Use of psychoactive drugs in ADHD within the previous month: Methylphenidate, Amphetamine, Atomoxetine, Modafinil and Antidepressants whatever the class.
- •Use of dietary supplementation, other than vitamins, within the last 3 months.
- •Use of ketogenic diet within the last 3 months.
- •Allergy to fish or other sea products.
- •Soy allergy.
- •Absence of coverage by social security.
研究组 & 干预措施
PS-OMEGA 3, capsules twice daily
Vayarin®, supplementation of n-3 PUFA: each capsule contains 8.5 mg of docosahexaenoic acid (DHA), 21.5 mg of eicosapentaenoic acid (EPA) and 75 mg of phosphatidylserine.
干预措施: Vayarin®, supplementation of n-3 PUFA (Drug)
PLACEBO, capsules twice daily
The placebo will be made of cellulose and a small amount of fish powder to maintain the double-blind in odor and taste. The supplementation in n-3 PUFA in the placebo group may be considered as negligible. Placebo will be administered as indistinguishable capsules, identical to the active product.
干预措施: PLACEBO (Drug)
结局指标
主要结局
Reduction of the ADHD-rating scale IV inattentive subscore in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment.
时间窗: 12 weeks
The ADHD Rating Scale-IV quantifies each of the 18 symptoms of ADHD on a 0 to 3 scale, with a maximum score of 54 points. Nine of the 18 items score for inattention while the nine others assess hyperactivity with a maximum of 27 points each. The discriminative value of these two subscales was validated, allowing their individual use.
次要结局
- After 24 weeks of treatment, change in quality of life score (EFIQUACEE questionnaire).(24 weeks)
- Evolution of eythrocytes lipid profiles in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment.(12 weeks)
- Number of subjects with a reduction in the frequency of seizures ≥ 50%, in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.(12 weeks)
- Reduction of TOVA total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.(12 weeks)
- Change in quality of life score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.(12 weeks)
- Evolution of plasma lipid profiles in subjects assigned to supplementation of PS-Omega 3 in comparison with the placebo group after 12 weeks of treatment.(12 weeks)
- After 24 weeks of treatment, description of the total score of ADHD Rating Scale.(24 weeks)
- After 24 weeks of treatment, erythrocyte lipid levels before and after treatment.(24 weeks)
- Tolerance of a supplementation of PS-Omega 3.(36 weeks)
- Reduction of the ADHD Rating Scale-IV total score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.(12 weeks)
- Proportion of subjects with a normalized TOVA score in the PS-Omega 3 group compared with the placebo group after 12 weeks of treatment.(12 weeks)
- After 24 weeks of treatment, proportion of subjects with a normalized TOVA score.(24 weeks)
- After 24 weeks of treatment, description of the total score of TOVA.(24 weeks)
- After 24 weeks of treatment, plasma lipid levels before and after treatment.(24 weeks)