Folinic Acid in Children With Autism Spectrum Disorders

Study Overview
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Brief Summary
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The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

Detailed Description
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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

Official Title
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Evaluation of the Efficiency of Folinic Acid in Children With Autism Spectrum Disorders: a Pilot Study EFFET

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: FOLINORAL
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br>treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks | Drug: FOLINORAL<br>* Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks<br>* Other names: Folinic acid;|
| Placebo Comparator: control<br>treatment with one capsule of placebo twice a day during 12 weeks | Other: Placebo<br>* Placebo 5mg twice a day (10 mg per day) during 12 weeks<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of severity of autistic symptoms with standardized scale ADOS (Autism Diagnosis Observation Scale) | 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 | change in ADOS scale at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the reduction of autistic symptom perceived by parents with a heteroevaluation scale : SRS (social responsiveness scale) | - 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 treatment | Change in SRS at 12 weeks | 
| evaluate the constancy of auto antibodies anti-FRα | Serum dosage of auto antibodies anti-FRα at T0 and at 12 weeks to evaluate the constancy of auto antibodies anti-FRα | change of auto antibodies anti-FRα at 12 weeks |