Iron Status in Autism Spectrum Disorders | NCT06441734

Studies
Iron Status in Autism Spectrum Disorders

NCT06441734

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Jul 16, 2024Actual

Enrollment

46Estimated

Phase

Not provided

Conditions

Anemia, Iron Deficiency

Interventions

cbc serum ferritin serum iron

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2024Estimated

Primary Completion Date

Jun 2, 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

May 29, 2024

First Submission Date that Met QC Criteria

Jun 3, 2024

First Posted Date

Jun 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2024

Last Update Posted Date

Jul 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group			Diagnostic Test: cbc serum ferritin serum iron
control group			Diagnostic Test: cbc serum ferritin serum iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cbc serum ferritin serum iron	Diagnostic Test	by using sample of blood to do cbc and serum ferritin and serum iron during 1year	control group study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iron status in autism spectrum disorders	by cbc serum ferritin serum iron	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age below 2 years and above 12 years
having an infection or inflammatory conditions chronic physical illness
receiving iron supplementation

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

children age from 2years to 12 years not having an infection or inflammatory conditions or physical illness

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
esraa hefzy shaker	Contact	01090930692		esraahefzy31@gmail.com
emad eldeen mahmoud hammad, professor	Contact	01223559943

Overall Officials

Name	Affiliation	Role
khalaf abdelaal said, lecturer	Assiut University	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33972922	Result	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.

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases