Autism, Vitamin D Deficiency
Conditions
Brief 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.
Detailed description
data is still being collected
Interventions
DRUGLiquid Vitamin D
300 IU/Kg/day not to exceed 10,000 IU/day.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Autism from DSM-IV TR and ADOS * Moderate but less than severe on CGI-Severity scale * IQ \> 40 * ZRT 25(OH)D blood spot test \< 30 ng/ml * Age 3-8 years old
Exclusion criteria
* Developmental delays prior to 12 months of age * history of head trauma * seizure in the past year * bleeding disorder * history of kidney or liver disease * clinically significant low white blood cell count * PDD-NOS, Rett's syndrome, Childhood Disintegrative Disorder or Fragile X syndrome * current supplementation with Vitamin D, Vitamin A or cod-liver oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale - Improvement (CGI-I) | Baseline and 12 weeks from Baseline | 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. |
Countries
United States
Outcome results
None listed