Folinic Acid in Children With Autism Spectrum Disorders (EFFET)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Other: Placebo; Drug: FOLINORAL

Study type: Interventional

Funder types: Other

Identifiers

NCT02551380

2015-000955-25

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)
2. Children aged 3 to 10 years
3. Weight> 10 kg
4. Language impairment (based on the medical assessment)
5. Ability to maintain other therapies started before the study
6. No changes of therapeutic treatments within the 8 weeks before the start of the study

Exclusion criteria

1. 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)
2. Antipsychotic treatment (including treatment with Risperidone)
3. Vitamin or mineral supplementation exceeding guidelines
4. Children with severe irritability (Aberrant Behavior Checklist> 17)
5. Gastroesophageal reflux disease
6. Any known renal or liver disease
7. Child born premature (<37SA)
8. Known intolerance to lactose
9. Hypersensitivity / allergic reaction to calcium folinate
10. The sibling children with autism spectrum disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups, including a placebo group

Treated

Experimental group

Description:

treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks

Treatment:

Drug: FOLINORAL

control

Placebo Comparator group

Description:

treatment with one capsule of placebo twice a day during 12 weeks

Treatment:

Other: Placebo