NCT02222311

Brief Summary

The investigators wish to study the effect of Vitamin D on the development of autism in children. The investigators will also investigate the environmental and genetic influences on the level of Vitamin D in children with autism.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

3 years

First QC Date

August 11, 2014

Last Update Submit

August 20, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of Vitamin D

    Blood samples of patients with and without autism with be taken and the level of vitamin D in their serum will be determined (international units).

    One day

Secondary Outcomes (1)

  • Effect of environment on Vitamin D level

    One week

Study Arms (3)

Autistic Children

Children diagnosed with autism spectrum disorder according to the criteria of the Diagnostic Statistical Manual-V will have blood samples taken for laboratory analysis.

Other: Blood Samples

Healthy Children

Children with no developmental or physical diseases will have blood samples taken for laboratory analysis.

Other: Blood Samples

Children with Attention Deficit Disorder

Blood samples from children with Attention Deficit Disorder will be measured for Vitamin D and oxidative stress markers.

Other: Blood Samples

Interventions

Autistic ChildrenChildren with Attention Deficit DisorderHealthy Children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with autism who have presented to the Child Development Institute at the Hillel Yaffe Medical Center and from pediatric neurology community clinics. The control groups include healthy age-matched children and children with Attention Deficit Disorder (ADD) who have presented to the Child Development Institute at the Hillel Yaffe Medical Center and from pediatric neurology community clinics.

You may qualify if:

  • Autistic children
  • Healthy children
  • Children with ADD

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Muhammad Mahajnah, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 21, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2017

Study Completion

April 1, 2018

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations