Folinic Acid in Children With Autism Spectrum Disorders
NCT ID: NCT02551380
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2015-10-31
2018-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treated
treatment with Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
FOLINORAL
Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
control
treatment with one capsule of placebo twice a day during 12 weeks
Placebo
Placebo 5mg twice a day (10 mg per day) during 12 weeks
Interventions
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FOLINORAL
Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
Placebo
Placebo 5mg twice a day (10 mg per day) during 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
3 Years
10 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Bruno Leheup, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
CHU NANCY- Hopital Brabois Enfants
Locations
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CHU Nancy-Hopital Brabois Enfants
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-000955-25
Identifier Type: -
Identifier Source: org_study_id
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