Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study "EFFET"
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale)
研究概览
简要总结
The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.
详细描述
The aim of this study is to realise a pilot study in France in order to evaluate the efficiency of folinic acid in treatment of autism spectrum disorder and get first estimations about prevalence of auto antibodies anti-FRα in France.
The study is a randomized controlled trial monocentric,evaluating folinic acid 10mg per day versus placebo, in single-blind during 12 weeks.
Primary objective : The primary objective is to evaluate the efficiency of folinic acid (calcium folinate) 5mg twice a day during 12 weeks on reduction of autistic troubles, particularly on communication and social interaction
Secondary objective :
- Evaluate the efficiency of folinic acid on reduction of autistic symptoms perceived by parents
- Evaluate the constancy of auto antibodies anti-FRα rates
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist)
- •Children aged 3 to 10 years
- •Weight> 10 kg
- •Language impairment (based on the medical assessment)
- •Ability to maintain other therapies started before the study
- •No changes of therapeutic treatments within the 8 weeks before the start of the study
排除标准
- •Treatment may impair folate metabolism (methotrexate, anticonvulsivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2)
- •Antipsychotic treatment (including treatment with Risperidone)
- •Vitamin or mineral supplementation exceeding guidelines
- •Children with severe irritability (Aberrant Behavior Checklist> 17)
- •Gastroesophageal reflux disease
- •Any known renal or liver disease
- •Child born premature (<37SA)
- •Known intolerance to lactose
- •Hypersensitivity / allergic reaction to calcium folinate
- •The sibling children with autism spectrum disorders
研究组 & 干预措施
Treated
treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
干预措施: FOLINORAL (Drug)
control
treatment with one capsule of placebo twice a day during 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale)
时间窗: change in ADOS scale at 12 weeks
Autistic symptoms (particularly communication and social interaction) measured by standardized scale ADOS (Autism Diagnosis Observation Scale) : comparison of score between folinic acid group and placebo at T0 et after 12 weeks of treatment
次要结局
- Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)(Change in SRS at 12 weeks)
- evaluate the constancy of auto antibodies anti-FRα(change of auto antibodies anti-FRα at 12 weeks)