Influence of Vitamin D Deficiency on the Development of Autism

August 20, 2014 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Autistic children
  • Healthy children
  • Children with ADD

Exclusion Criteria:

  • All others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Vitamin D
Time Frame: One day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of environment on Vitamin D level
Time Frame: One week
All participant blood samples will be measured for levels of oxidative stress markers and antioxidants.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0038-14-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism

Clinical Trials on Blood Samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe