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OpenTrials
Completed

NCT Number: NCT01535508

Open Label Clinical Trial of Vitamin D in Children With Autism

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Avitaminosis Child Development Disorders, Pervasive Deficiency Diseases Malnutrition Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

data is still being collected

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid Vitamin D

Drug

300 IU/Kg/day not to exceed 10,000 IU/day.

Other names: Ddrops

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2012
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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