Open Label Clinical Trial of Vitamin D in Children With Autism
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism|
- Clinical Global Impression Scale - Improvement (CGI-I) [ Time Frame: Baseline and 12 weeks from Baseline ] [ Designated as safety issue: No ]Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.
|Study Start Date:||February 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Experimental: Liquid Vitamin D||
Drug: Liquid Vitamin D
300 IU/Kg/day not to exceed 10,000 IU/day.
Other Name: Ddrops
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535508
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Robert L Hendren, DO||University of California, San Francisco|