Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

The researchers will be testing a specific dietary supplement, methylcobalamin (vitamin B12).

Follow-up assessments with their clinical team will take place over the 12-week study period so that the researchers 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.

It had two arms (groups): A (active comparator) and B (placebo comparator).

Methyl-B12.

Saline placebo.

The registry classes the interventions as drug and other.

More on the Plan

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).

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

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 3 years up to 8 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: clinical evidence of seizure disorder; recent surgery; active infection with fever.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Each person switched between Cyanocobalamin (Vitamin B12) and the comparison at some point, usually with a gap in between.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2005-07 with completion listed for 2009-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Secondary measures:NEPSY, ABC, PPVT, SB:V, PDRF, MCDI, PIA-CV, and CARS.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.