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Open Label Clinical Trial of Vitamin D in Children With Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535508
First Posted: February 17, 2012
Last Update Posted: November 7, 2016
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.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose

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 Intervention Phase
Autism Vitamin D Deficiency Drug: Liquid Vitamin D Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: February 2012
Study Completion Date: December 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liquid Vitamin D Drug: Liquid Vitamin D
300 IU/Kg/day not to exceed 10,000 IU/day.
Other Name: Ddrops

Detailed Description:
data is still being collected
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01535508


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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01535508     History of Changes
Other Study ID Numbers: VitD11-06899
First Submitted: February 14, 2012
First Posted: February 17, 2012
Last Update Posted: November 7, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Autistic Disorder
Vitamin D Deficiency
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents