Autism in ChildrenNCT03601468
Association Between Autism and Iron Deficiency
An observational study of Autism in Children, run by Assiut University.
Trial summary
Association between Autism and Iron Deficiency in Children Diagnosed Autism Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Autism in Children
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Sep 2019
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Association between Autism and Iron Deficiency in Children Diagnosed Autism
Who may be able to join
- All children with autism above 2 years to and do not take supplements of iron or vitamins.
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association Between Autism and Iron Deficiency in Children Diagnosed Autism
Association between Autism and Iron Deficiency in Children Diagnosed Autism
Read the 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.
- Conditions
- Autism in Children
- Medical subject headings
- Autistic Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggressive autism picture
Identify the relationship between ID/IDA which may increase the severity of autistic symptoms in children with ASD.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Mohammed Mostafa, Assiut University
- Investigators
- Mohammed A Mohammed, Residant, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601468
- Sponsor's protocol ID
- Assiut university 2018
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Autism and Iron Deficiency in Children Diagnosed Autism
- ClinicalTrials.gov ID
- NCT03601468
- Acronym / sponsor ID
- Assiut university 2018
- Conditions
- Autism in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- 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.
Association between Autism and Iron Deficiency in Children Diagnosed Autism
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Association between Autism and Iron Deficiency in Children Diagnosed Autism
Key inclusion criteria (1 listed)
- All children with autism above 2 years to and do not take supplements of iron or vitamins.
Key exclusion criteria (4 listed)
- • children less than 2 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed A Mohammed, Residant principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Autism in Children, run by Assiut University.
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 1 inclusion and 4 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Kotb A Metwally, Professor (0100 391 2599, kotab.khalil@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggressive autism picture (time frame: One year). 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 26 Jul 2018.