Open Label Clinical Trial of Vitamin D in Children With Autism

Phase 2

Completed

• Conditions: Autism; Vitamin D Deficiency
• Interventions: Drug: Liquid Vitamin D

• Registration Number: NCT01535508
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

data is still being collected

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Disposition First Submitted: 2019-09-24
• Status Verified: 2019-10
• Disposition First Submitted QC: 2019-10-08
• Last Update Submitted: 2019-10-08
• Disposition First Posted: 2019-10-09
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liquid Vitamin D	Liquid Vitamin D	-

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale - Improvement (CGI-I)	Baseline and 12 weeks from Baseline	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States