Association Between Autism and Iron Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03601468
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Information provided by (Responsible Party):
Mohammed Ali Mohammed Mostafa, Assiut University

Brief Summary:
Association between Autism and Iron Deficiency in Children Diagnosed Autism

Condition or disease
Autism in Children

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 : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Association Between Autism and Iron Deficiency in Children Diagnosed Autism
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Association between Autism and Iron Deficiency in Children Diagnosed Autism

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03601468

Contact: Kotb A Metwally, Professor 0100 391 2599
Contact: Eman FA Gad, Lectuer 0111 519 1158

Sponsors and Collaborators
Assiut University
Principal Investigator: Mohammed A Mohammed, Residant Assiut University

Responsible Party: Mohammed Ali Mohammed Mostafa, Assiut university, Assiut University Identifier: NCT03601468     History of Changes
Other Study ID Numbers: Assiut university 2018
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Autistic Disorder
Anemia, Iron-Deficiency
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases