Open Label Clinical Trial of Vitamin D in Children With Autism

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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