Open Label Clinical Trial of Vitamin D in Children With Autism

Completed · Phase 2/Phase 3

Conditions studied: Autism, Vitamin D Deficiency

In brief

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.

Key facts

Study ID: NCT01535508
Run by: University of California, San Francisco
People needed: 10
Starts: 2012-02-01
Expected to finish: 2015-12-01
Last updated by the study team: 2019-10-09

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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