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Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism

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ClinicalTrials.gov Identifier: NCT00273650
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:

We will be testing a specific dietary supplement, methylcobalamin (vitamin B12). Follow-up assessments with our clinical team will take place over the 12-week study period so that we can record any changes in development. The main goal of this study is to determine if subcutaneous injections of vitamin B12 given every three days can positively affect behavior and development in children with autism.

Hypothesis: Methylcobalamin injections will improve measures of executive function, speech, and socialization in children with autism, and will be associated with metabolic improvement.


Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: methylcobalamin Other: saline placebo Phase 2 Phase 3

Detailed Description:

Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes (Keller & Persico, 2003), epigenetic effects (Beaudet, 2002), and environmental factors (London, 2000). The increase in the prevalence of autistic spectrum disorders from 4-5/10,000 in the 1980s to 30-60/10,000 in the last decade has raised great concern (Bertrand et al., 2001; DeStefano et al., 2004; Steinhausen et al., 1986; Yeargin-Allsopp et al., 2003). Research into potential therapeutic interventions designed to ameliorate the metabolic and clinical symptoms of autism is urgently needed to reduce the enormous public health burden of this disorder and to improve the quality of life for affected children and their families. Nutritional supplementation through subcutaneous injections of methyl B12 is a current treatment for children with autism that has anecdotal reports of remarkable clinical improvements and few side effects. However there are no published studies to support its clinical benefit.

Comparison: Injections of methylcobalamin compared to injections of sterile saline over a six week period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind Placebo Controlled, Cross-over Trial of Subcutaneous B12 on Behavioral and Metabolic Measures in Children With Autism.
Study Start Date : July 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Methyl-B12
 Drug: methylcobalamin
Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.
Other Names:
  • Vitamin B-12
  • Methyl-B12
Placebo Comparator: B
Saline placebo
 Other: saline placebo
Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.
Other Name: saline


Outcome Measures
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Primary Outcome Measures :
  1. Primary measure is the Clinical Global Impression Scale -Improvement supplemented by videos taken at all visits and rated blindly to measure executive function, speech, and language, and socio-economic development. [ Time Frame: 12 Weeks to 6 Months ]

Secondary Outcome Measures :
  1. Secondary measures:NEPSY, ABC, PPVT, SB:V, PDRF, MCDI, PIA-CV, and CARS. [ Time Frame: 12 Weeks to 6 Months ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and the Autism Diagnostic Observation Scale (ADOS).
  • Age 3 to 8 years
  • IQ of 50 or above
  • Willingness of parents to administer subcutaneous methyl B12.
  • Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 12 week intervention or wait list.

Exclusion Criteria:

  • Clinical evidence of seizure disorder
  • Cancer
  • Recent surgery
  • Active infection with fever
  • Fragile X or other known genetic cause of autism
  • Bleeding disorder
  • Perinatal brain injury (e.g. cerebral palsy)
  • Current use of any methyl B12 product
  • Evidence for malnutrition seen in abnormal albumin level
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273650


Locations
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United States, California
UC Davis MIND Institute
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Robert L Hendren, D.O. University of California, Davis
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00273650    
Other Study ID Numbers: MB12-AUT
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
Autism
Placebo
B12
 Controlled
Complementary Alternative Medicine
Vitamin Supplement
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
 Vitamin B 12
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex