Open Label Clinical Trial of Vitamin D in Children With Autism
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation,
titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in
vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.
The study will determine if initial safety and effect estimates predict that a double blind
randomized control trial (RCT) with a larger set of patients will be worthwhile in the
localization of this treatment aimed at improving the symptoms of ASDs.
Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core
symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior,
and sleep, as determined by parental and clinical evaluation scales.