Pulmonary Function TestsNCT05277610
Iron Status and Lung Function in Pediatric Asthma
An observational study of Pulmonary Function Tests, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Pulmonary Function Tests
- What is being tested?
- iron studies
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Oct 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Asthmatic children with and without iron deficiency anemia
Who may be able to join
- 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
Who cannot join
- chronic lung diseases other than asthma Severe systemic illnesses such as liver, renal diseases, and nutritional disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Status and Its Relation to Lung Function in Pediatric Asthmatics
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
Read the 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.
- Conditions
- Pulmonary Function Tests
- Being tested
- iron studies
- Keywords
- asthma, pediatric, iron deficiency anemia
- Medical subject headings
- Asthma, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron studiesDiagnostic test
Pulmonary function testing was performed using standardized spirometry for asthmatic patients with iron deficiency anemia and those without iron deficiency anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
improved asthma control
higher asthma control test
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jun 2019
- Primary completion1 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Function TestsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Omara, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277610
- Sponsor's protocol ID
- AinShamsU555
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Status and Its Relation to Lung Function in Pediatric Asthmatics
- ClinicalTrials.gov ID
- NCT05277610
- Acronym / sponsor ID
- AinShamsU555
- Conditions
- Pulmonary Function Tests
- Keywords
- asthma, pediatric, iron deficiency anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 14 Mar 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Asthmatic children with and without iron deficiency anemia
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- chronic lung diseases other than asthma Severe systemic illnesses such as liver, renal diseases, and nutritional disorders
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 |
|---|---|---|
| iron studiesPulmonary function testing was performed using standardized spirometry for asthmatic patients with iron deficiency anemia and those without iron deficiency anemia | Diagnostic test | – |
Primary outcome
improved asthma control
Time frame: 2 months
higher asthma control test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Function Tests, run by Ain Shams University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved asthma control (time frame: 2 months). 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 14 Mar 2022.