- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601468
Association Between Autism and Iron Deficiency
Association Between Autism and Iron Deficiency in Children Diagnosed Autism
Study Overview
Status
Conditions
Detailed Description
Autism is a behaviorally defined complex neurodevelopmental syndrome characterized by impairments in social communication, by the presence of restricted and repetitive behaviors, interests and activities, and by abnormalities in sensory reactivity.
Autism is a severe, life-long developmental disorder that compromises functioning across multiple domains including social behavior, language, sensory function, and ritualistic/repetitive behaviors and interests. While the etiology of autism is complex and not fully understood, strong evidence from twin and family studies suggests a large genetic contribution .
Autism is caused by a combination of genetic and environment factors. Risk factors include certain infections during pregnancy such as rubella as well as valproic acid, alcohol or cocaine use during pregnancy.
The number of children known to have autism has increased dramatically since the 1980's.The reviews of epidemiology in estimating the global prevalence is that one to two cases of autism exist per 2,000 people, and about six per 1,000 people have Autistic Spectrum Disorders (ASD) .
According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), a guide created by the American Psychiatric Association used to diagnose mental disorders, people with Autism have:
- Difficulty with communication and interaction with other people
- Restricted interests and repetitive behaviors
- Symptoms that hurt the person's ability to function properly in school, work, and other areas of life.
Iron deficiency (ID) is the most common and persevering nutritional disorder and continues to be an important public health problem worldwide. Specifically in children in the first years of life, hemoglobin (HGB) levels below 11 g/dL have been related to negative cognitive, social, and emotional effects that may lead to irreversible behavioral squeals, even after appropriate treatment.
A reduction of iron levels in the brain may be accompanied by changes in serotonergic and dopaminergic systems, cortical networks, and myelination.
Iron deficiency (ID) cause negative outcomes on psychomotor and behavioral development of infants and young children. Children with autism are under risk for ID and this condition may increase the severity of psychomotor and behavioral problems,The association between iron deficiency and developmental problems such as global developmental delay is thought to be bidirectional. Iron deficiency impairs the processes of neurotransmitter metabolism and myelin formation, as well as altering energy metabolism in the brain - effects that have been theorised to cause behavioural and cognitive developmental delays in children.
Thus, it can be considered that ID/IDA (iron deficiency anemia) may increase the severity of autistic symptoms in children with ASD.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All children with autism above 2 years to and do not take supplements of iron or vitamins.
Exclusion Criteria:
• children less than 2 years old.
- Children with other chronic neurological disorders or physical illness than Autism.
- children with infection or other inflammatory conditions were excluded from the study,
- children who received iron supplements during the last 3 months and / or who were on any dietary restrictions and children who are inpatients in rehabilitation centers
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aggressive autism picture
Time Frame: One year
|
Identify the relationship between ID/IDA which may increase the severity of autistic symptoms in children with ASD.
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammed A Mohammed, Residant, Assiut University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Assiut university 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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