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Open Label Clinical Trial of Vitamin D in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535508
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autism Vitamin D Deficiency Drug: Liquid Vitamin D Phase 2 Phase 3

Detailed Description:
data is still being collected

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism
Study Start Date : February 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Liquid Vitamin D Drug: Liquid Vitamin D
300 IU/Kg/day not to exceed 10,000 IU/day.
Other Name: Ddrops

Primary Outcome Measures :
  1. Clinical Global Impression Scale - Improvement (CGI-I) [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535508

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Robert L Hendren, DO University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01535508    
Other Study ID Numbers: VitD11-06899
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Vitamin D Deficiency
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents