Autism Trial with Vitamin D

Print Article Download PDF

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.

Eligibility

  • 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

What is involved?

  • 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

Contact information