Iron Status and Lung Function in Pediatric Asthma | NCT05277610

Studies
Iron Status and Lung Function in Pediatric Asthma

NCT05277610

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 14, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Pulmonary Function Tests

Interventions

iron studies

Countries

Egypt

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Oct 1, 2019Actual

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Mar 4, 2022

First Posted Date

Mar 14, 2022Actual

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

Mar 4, 2022

Last Update Posted Date

Mar 14, 2022Actual

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

Iron has a variable role regarding asthma and respiratory function. In addition, iron deficiency may affect spirometry results in asthmatic children. So, we aimed to assess the effect of ion status on lung function in childhood asthma

Detailed Description

This cross-sectional study included fifty asthmatic children in the age group of 6-16 years. Asthmatic patients were classified according to their complete blood count and iron profile into 2 groups: group 1; asthmatic children without iron deficiency anemia (IDA), group 2; asthmatic children with IDA. All patients underwent full history taking, clinical examination, laboratory investigations, asthma control test, and pulmonary function tests.

Pulmonary function testing was performed using standardized spirometry. Lung function was measured by forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, and maximal mid-expiratory flow (MMEF 25-75%) of FVC. both patients' groups are compared.

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

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iron studies	Diagnostic Test	Pulmonary function testing was performed using standardized spirometry for asthmatic patients with iron deficiency anemia and those without iron deficiency anemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improved asthma control	higher asthma control test	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of bronchial asthma: The diagnosis of bronchial asthma in the studied children was based on clinical examination The diagnosis of iron deficiency anemia was supported by criteria provided and updated by the World Health Organization

Exclusion Criteria:

chronic lung diseases other than asthma Severe systemic illnesses such as liver, renal diseases, and nutritional disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Asthmatic children with and without iron deficiency anemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heba Omara		Cairo	Lecturer/Instructor	11111111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided