Folinic Acid in Children With Autism Spectrum Disorders
- Conditions
- Autism Spectrum Disorder
- Interventions
- Drug: FOLINORALOther: Placebo
- Registration Number
- NCT02551380
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treated FOLINORAL treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks control Placebo treatment with one capsule of placebo twice a day during 12 weeks
- Primary Outcome Measures
Name Time Method Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale) 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
- Secondary Outcome Measures
Name Time Method Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale) Change in SRS at 12 weeks - Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale)
o Comparison of score between folinic acid group and placebo group at T0 (inclusion) and after 12 weeks of treatmentevaluate the constancy of auto antibodies anti-FRα change of auto antibodies anti-FRα at 12 weeks Serum dosage of auto antibodies anti-FRα at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRα
Trial Locations
- Locations (1)
CHU Nancy-Hopital Brabois Enfants
🇫🇷Vandoeuvre les Nancy, France