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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03601468
Other study ID # Assiut university 2018
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 1, 2019

Study information

Verified date July 2018
Source Assiut University
Contact Kotb A Metwally, Professor
Phone 0100 391 2599
Email kotab.khalil@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Association between Autism and Iron Deficiency in Children Diagnosed Autism


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Aggressive autism picture Identify the relationship between ID/IDA which may increase the severity of autistic symptoms in children with ASD. One year