Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): methylcobalamin; saline placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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 intervention name(s): Vitamin B-12; Methyl-B12; saline
Intervention MeSH terms: Vitamin B 12
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; Placebo; B12; Controlled; Complementary Alternative Medicine; Vitamin Supplement