Open Label Clinical Trial of Vitamin D in Children With A... | NCT01535508

Studies
Open Label Clinical Trial of Vitamin D in Children With Autism

NCT01535508

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Oct 9, 2019Actual

Enrollment

10Actual

Phase

Phase 2Phase 3

Conditions

Autism
Vitamin D Deficiency

Interventions

Liquid Vitamin D

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Sep 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 14, 2012

First Submission Date that Met QC Criteria

Feb 16, 2012

First Posted Date

Feb 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 24, 2019

Certification/Extension First Submitted that Passed QC Review

Oct 8, 2019

Certification/Extension First Posted Date

Oct 9, 2019Actual

Last Update Submitted Date

Oct 8, 2019

Last Update Posted Date

Oct 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liquid Vitamin D	Experimental		Drug: Liquid Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liquid Vitamin D	Drug	300 IU/Kg/day not to exceed 10,000 IU/day.	Liquid Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Global Impression Scale - Improvement (CGI-I)	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.	Baseline and 12 weeks from Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert L Hendren, DO	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided