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Open Label Clinical Trial of Vitamin D in Children With Autism

This study is currently recruiting participants.
Verified September 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01535508
First received: February 14, 2012
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Autism Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535508

Contacts
Contact: Robert L Hendren, DO 415-476-7198 Robert.Hendren@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Felicia Widjaja, MPH     415-476-7803     felicia.widjaja@ucsf.edu    
Principal Investigator: Robert L Hendren, DO            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Robert L Hendren, DO University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01535508     History of Changes
Other Study ID Numbers: VitD11-06899
Study First Received: February 14, 2012
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013