Anemia, Iron DeficiencyNCT06441734
Iron Status in Autism Spectrum Disorders
An observational study of Anemia, Iron Deficiency, run by Assiut University.
Trial summary
to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- cbc serum ferritin serum iron
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2024to Jul 2025
- 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 to 12 years
- All sexes
- Child
Study population: children age from 2years to 12 years not having an infection or inflammatory conditions or physical illness
Who may be able to join
- children who are diagnosed with autism spectrum disorder according to DSM -V
- not having infection inflammatory conditions chronic physical illness
- children who are not receiving iron supplementation
Who cannot join
- age below 2 years and above 12 years
- having an infection or inflammatory conditions chronic physical illness
- receiving iron supplementation
Trial locations and contacts
No sites are listed yet.
emad eldeen mahmoud hammad, professor contact
About this study
Official title: Iron Status in Autism Spectrum Disorders in Children Attending Assiut Pediatric University Hospital
to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group
- Conditions
- Anemia, Iron Deficiency
- Being tested
- cbc serum ferritin serum iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cbc serum ferritin serum ironDiagnostic test
by using sample of blood to do cbc and serum ferritin and serum iron during 1year
| Study group | Role | What they receive |
|---|---|---|
| study group | Not described Receives: Diagnostic Test: cbc serum ferritin serum iron | |
| control group | Not described Receives: Diagnostic Test: cbc serum ferritin serum iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron status in autism spectrum disorders
by cbc serum ferritin serum iron
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start2 Aug 2024 (estimated)
- Primary completion2 Jun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esraa hefzy shaker mostafa, Assiut University
- Investigators
- khalaf abdelaal said, lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441734
- Sponsor's protocol ID
- anemia in autism
- Status last verified
- Jul 2024
- First submitted
- 29 May 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Beltagi M. Autism medical comorbidities. World J Clin Pediatr. 2021 May 9;10(3):15-28. doi: 10.5409/wjcp.v10.i3.15. eCollection 2021 May 9.
PubMed 33972922
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Status in Autism Spectrum Disorders in Children Attending Assiut Pediatric University Hospital
- ClinicalTrials.gov ID
- NCT06441734
- Acronym / sponsor ID
- anemia in autism
- Conditions
- Anemia, Iron Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (estimated)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Jun 2024 (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.
to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: cbc serum ferritin serum iron |
| control group | – | Diagnostic Test: cbc serum ferritin serum iron |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- children age from 2years to 12 years not having an infection or inflammatory conditions or physical illness
Key inclusion criteria (3 listed)
- children who are diagnosed with autism spectrum disorder according to DSM -V
- not having infection inflammatory conditions chronic physical illness
- children who are not receiving iron supplementation
Key exclusion criteria (3 listed)
- age below 2 years and above 12 years
- having an infection or inflammatory conditions chronic physical illness
- receiving iron supplementation
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 |
|---|---|---|
| cbc serum ferritin serum ironby using sample of blood to do cbc and serum ferritin and serum iron during 1year | Diagnostic test | control group, study group |
Primary outcome
iron status in autism spectrum disorders
Time frame: 1 year
by cbc serum ferritin serum iron
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Results publication: PubMed 33972922Al-Beltagi M. Autism medical comorbidities. World J Clin Pediatr. 2021 May 9;10(3):15-28. doi: 10.5409/wjcp.v10.i3.15. eCollection 2021 May 9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
emad eldeen mahmoud hammad, professor contact
khalaf abdelaal said, lecturer study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Iron Deficiency, 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 3 inclusion and 3 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 16 Jul 2024. 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 esraa hefzy shaker (01090930692, esraahefzy31@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iron status in autism spectrum disorders (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441734, which also lists 1 linked publication.
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 16 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.