Open Label Clinical Trial of Vitamin D in Children With Autism
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 14, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 9, 2019
October 1, 2019
3.6 years
February 14, 2012
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Liquid Vitamin D
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Hendren, DO
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2012
First Posted
February 17, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
October 9, 2019
Record last verified: 2019-10