Open Label Clinical Trial of Vitamin D in Children With Autism

NCT ID: NCT01535508

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-12-31

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.

Detailed Description

data is still being collected

Conditions

Autism; Vitamin D Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liquid Vitamin D

Group Type: EXPERIMENTAL

Liquid Vitamin D

Intervention Type: DRUG

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

Interventions

Liquid Vitamin D

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

Intervention Type: DRUG

Other Intervention Names

Ddrops

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L Hendren, DO

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

VitD11-06899

Identifier Type: -

Identifier Source: org_study_id