Phase 3
Completed N=57
Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism
Autistic Disorder
Source: ClinicalTrials.gov NCT01039792 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Clinical Global Impression-Improvement (CGI-I) — 3.1; 2.4 CGI- Improvement
◆ Published Evidence
Highly cited
161citations · ~16 / year
Randomized, Placebo-Controlled Trial of Methyl B12 for Children with Autism.
Summary
The purpose of this study is to determine whether the supplement Methyl B12 is effective in treating some of the symptoms of Autism.
Linked Publications
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Randomized, Placebo-Controlled Trial of Methyl B12 for Children with Autism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression-Improvement (CGI-I) |
3.1; 2.4 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and/or the Autism Diagnostic Observation Scale (ADOS)
- Age 3 through 7 years
- IQ of 50 or above
- Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 8 week intervention
- Willingness to have blood drawn, without the use of a sedative prescription from the study doctor
Exclusion Criteria
- Bleeding disorder
- Cancer
- Seizure disorder
- Fragile X or other known genetic cause of autism
- Perinatal brain injury (i.e.: cerebral palsy)
- Other serious medical illnesses
- Current use of any B12 supplement
Data sourced from ClinicalTrials.gov (NCT01039792) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.