Open Label Clinical Trial of Vitamin D in Children With Autism

Vitamin D Deficiency Clinical Trial

Official title:

Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535508
• Other study ID #: VitD11-06899
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

data is still being collected

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Vitamin D Deficiency

Intervention

Drug:
• Liquid Vitamin D
300 IU/Kg/day not to exceed 10,000 IU/day.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression Scale - Improvement (CGI-I)	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.	Baseline and 12 weeks from Baseline