NCT06441734

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

May 29, 2024

Last Update Submit

July 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • iron status in autism spectrum disorders

    by cbc serum ferritin serum iron

    1 year

Study Arms (2)

study group

Diagnostic Test: cbc serum ferritin serum iron

control group

Diagnostic Test: cbc serum ferritin serum iron

Interventions

by using sample of blood to do cbc and serum ferritin and serum iron during 1year

control groupstudy group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • khalaf abdelaal said, lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

esraa hefzy shaker

CONTACT

emad eldeen mahmoud hammad, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 4, 2024

Study Start

August 2, 2024

Primary Completion

June 2, 2025

Study Completion

July 1, 2025

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share