Autism Trial with Vitamin D

Summary

Study director: Robert Hendren, DO
Sponsor: Ddrops
Recruiting?: No
Official study title: Open Label Clinical trial of Vitamin D3 Dosage Tolerability and Effect on Behavioral Measures in Children with Autism
ClinicalTrials.gov identifier: Pending
Conditions studied: Autistic disorder
Intervention: Vitamin D3 (cholecalciferol)
Phase: Phase II
Purpose: To observe the effects of Vitamin D supplementation on standard behavior measures in a small sample size of children with autism. The results will indicate whether a double blind placebo controlled trial with a larger sample size would be a worthwhile option.

Inclusion criteria:
- Child is 3-8 years old
- Child has a diagnosis of autistic disorder
- Child did not have developmental delays before the age of 12 months
- Child has CGI-S score of at least 4, but less than 7 at the Screening and Baseline visits
- English must be primary language of child
Exclusion criteria:
- Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder
- Diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS), Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder or Fragile X Syndrome
- History of neuroleptic malignant syndrome
- A seizure within the past year
- History of severe head trauma or stroke
- History or current evidence of any unstable medical conditions
- History of kidney or liver disease
- Known bleeding disorder, or history of failure to clot
- History of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia
- Known granulomatous disease (tuberculosis, sarcoidosis)
- Child may not be taking any psychoactive medications currently
- Taking the following medications or supplements: Cod-liver oil, Vitamin A, Thiazide Diuretics, Calcipotriene, Digoxin, Diltiazem, Verapamil, Cimetidine, Heparin

Testing: Behavioral assessments, cognitive testing, parent questionnaires, physical examinations, blood specimen collection, and vital signs
Frequency of visits: The study lasts 12 weeks and will involve 4 visits to UCSF, each visit about four weeks apart
Materials needed prior to evaluation: None
Costs: No costs will be charged for any of the study procedures