AutismNCT02222311
Influence of Vitamin D Deficiency on the Development of Autism
An observational study of Autism, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Blood Samples
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Autistic children
- Healthy children
- Children with ADD
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Muhammad Mahajnah, MD, PhD, 972-5-624-6959, mohamedm@hy.health.gov.il
Muhammad Mahajnah, MD, PhD
About this study
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.
- Conditions
- Autism
- Being tested
- Blood Samples
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplesOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Samples | |
| Healthy Children | Children with no developmental or physical diseases will have blood samples taken for laboratory analysis. Receives: 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. Receives: Other: Blood Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One day
Secondary outcomes (1)
Effect of environment on Vitamin D level
All participant blood samples will be measured for levels of oxidative stress markers and antioxidants.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222311
- Sponsor's protocol ID
- 0038-14-HYMC
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vitamin D Deficiency on the Development of Autism
- ClinicalTrials.gov ID
- NCT02222311
- Acronym / sponsor ID
- 0038-14-HYMC
- Conditions
- Autism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autistic Children | – | Other: Blood SamplesChildren diagnosed with autism spectrum disorder according to the criteria of the Diagnostic Statistical Manual-V will have blood samples taken for laboratory analysis. |
| Healthy Children | – | Other: Blood SamplesChildren with no developmental or physical diseases will have blood samples taken for laboratory analysis. |
| Children with Attention Deficit Disorder | – | Other: Blood SamplesBlood samples from children with Attention Deficit Disorder will be measured for Vitamin D and oxidative stress markers. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Autistic children
- Healthy children
- Children with ADD
Key exclusion criteria (1 listed)
- All others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Samples | Other | Autistic Children, Children with Attention Deficit Disorder, Healthy Children |
Primary outcome
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).
1 secondary outcome
Effect of environment on Vitamin D level
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Mahajnah, MD, PhD (972-5-624-6959, mohamedm@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Vitamin D (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.