Recurrent WheezesNCT05040269
Serum Levels of Vitamin D,Calcium and Magnesium in Preschool Recurrent Wheezers
An observational study of Recurrent Wheezes, run by Sohag University at 1 site in Egypt.
Trial summary
wheezing" is defined as a musical sound caused by the passage of air through narrow respiratory tract airways . Recurrent wheeze is defined as three or more episodes of parentally reported wheeze in the past 12 months of Various risk factors are associated with recurrent wheezing and asthma: small airway caliber… Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Recurrent Wheezes
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 May 2022
- 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 1 month to 6 years
- All sexes
- Child
Study population: The study will include any child with three or more episodes of parentally reported wheeze aged from 1 month to less than 6 years admitted at pediatric department of Sohag University Hospital.
Who may be able to join
- Any child with three or more episodes of parentally reported wheeze aged from 1 month to less than 6 years admitted at pediatric department of Sohag University Hospital.
Who cannot join
- patients with chronic lung and congenital heart diseases.
- Patients with body mass index (BMI) below 3rd percentile and those ≥ 85th percentile will be excluded to avoid effect of disturbed nutritional status on vitamin D level and occurrence of wheezing.
Trial locations and contacts
1 site in 1 country.
Mostafa M Abosdera, Prodessor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag
Osama R Elsherf, Professor
About this study
Official title: Serum Levels of Vitamine D,Calcium and Magnesium in Infants and Preschool Children With Recurrent Wheezing
wheezing" is defined as a musical sound caused by the passage of air through narrow respiratory tract airways . Recurrent wheeze is defined as three or more episodes of parentally reported wheeze in the past 12 months of Various risk factors are associated with recurrent wheezing and asthma: small airway caliber; decreased lung function at birth; viral respiratory infections; environmental pollution; pets; early daycare attendance; passive smoking; parental history of asthma or atopy; obesity; and socioeconomic factors.
Read the detailed description
There has been growing recognition of the critical extra-skeletal roles for vitamin D in recent years with an explosion of interest in vitamin D across health disciplines including lung disease. Recently, vitamin D was found to be low in patients with recurrent wheezes.
Vitamin D, whether produced in the skin upon sun exposure or ingested from various dietary sources, is converted in the liver to 25-hydroxyvitamin D [25(OH)D]. The latter is the major circulating form of vitamin D and is thus used for evaluating the vitamin D status of patients . The flesh of fatty fish (such as salmon, tuna, and mackerel) and fish liver oils are among the best sources of vitamin D and the fortified cereals and milk provide adequate amounts as well.
Studies in animal models and humans have demonstrated an association of low vitamin D concentrations with atopy and respiratory tract conditions. The mechanism that explains this association is still unclear. It has been suggested that this mechanism is due to the effects of vitamin D status on the regulation of the immune system.
The vitamin D receptor is expressed in various cells of the immune system, such as macrophages, monocytes, dendritic cells, and natural killer cells, as well as in B and T lymphocytes. Binding of the active form of vitamin D to its receptor leads to an increase in immunomodulatory activity that maintains the balance between the cellular immune response (Th1) and the humoral response (Th2), in addition to stimulating regulatory T cells.
Hypomagnesaemia (serum Mg level <0.74 mmol.L-1) has been also suggested to be associated with increased incidence of wheeze, airway hyperreactivity, and impairment of lung function. The mechanisms of action of magnesium (Mg) on respiratory airways are multiple and include relaxation of airways smooth muscle, bronchodilatation, anticholinergic effect, and stabilization of the mast cells
- Conditions
- Recurrent Wheezes
- Medical subject headings
- Respiratory Sounds
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of serum vitamin D, calcium and magnesium in infants and preschool recurrent wheezers
Serum vitamin D, calcium and magnesium venous blood sample (3ml) will be obtained from children with recurrent wheezes aged from 1 month to 6 years
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Recurrent WheezesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Alsoudy Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040269
- Sponsor's protocol ID
- Soh-Med-21-07-04
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Douros K, Everard ML. Time to Say Goodbye to Bronchiolitis, Viral Wheeze, Reactive Airways Disease, Wheeze Bronchitis and All That. Front Pediatr. 2020 May 5;8:218. doi: 10.3389/fped.2020.00218. eCollection 2020.
PubMed 32432064Ly NP, Gold DR, Weiss ST, Celedon JC. Recurrent wheeze in early childhood and asthma among children at risk for atopy. Pediatrics. 2006 Jun;117(6):e1132-8. doi: 10.1542/peds.2005-2271.
PubMed 16740815de Sousa RB, Medeiros D, Sarinho E, Rizzo JA, Silva AR, Bianca AC. Risk factors for recurrent wheezing in infants: a case-control study. Rev Saude Publica. 2016;50:15. doi: 10.1590/S1518-8787.2016050005100. Epub 2016 May 3.
PubMed 27143615Yang HK, Choi J, Kim WK, Lee SY, Park YM, Han MY, Kim HY, Hahm MI, Chae Y, Lee KJ, Kwon HJ, Ahn K, Kim J. The association between hypovitaminosis D and pediatric allergic diseases: A Korean nationwide population-based study. Allergy Asthma Proc. 2016 Jul;37(4):64-9. doi: 10.2500/aap.2016.37.3957.
PubMed 27401310
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Vitamine D,Calcium and Magnesium in Infants and Preschool Children With Recurrent Wheezing
- ClinicalTrials.gov ID
- NCT05040269
- Acronym / sponsor ID
- Soh-Med-21-07-04
- Conditions
- Recurrent Wheezes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 10 Sep 2021 (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.
wheezing" is defined as a musical sound caused by the passage of air through narrow respiratory tract airways . Recurrent wheeze is defined as three or more episodes of parentally reported wheeze in the past 12 months of Various risk factors are associated with recurrent wheezing and asthma: small airway caliber; decreased lung function at birth; viral respiratory infections; environmental pollution; pets; early daycare attendance; passive smoking; parental history of asthma or atopy; obesity; and socioeconomic factors.
Detailed description
There has been growing recognition of the critical extra-skeletal roles for vitamin D in recent years with an explosion of interest in vitamin D across health disciplines including lung disease. Recently, vitamin D was found to be low in patients with recurrent wheezes.
Vitamin D, whether produced in the skin upon sun exposure or ingested from various dietary sources, is converted in the liver to 25-hydroxyvitamin D [25(OH)D]. The latter is the major circulating form of vitamin D and is thus used for evaluating the vitamin D status of patients . The flesh of fatty fish (such as salmon, tuna, and mackerel) and fish liver oils are among the best sources of vitamin D and the fortified cereals and milk provide adequate amounts as well.
Studies in animal models and humans have demonstrated an association of low vitamin D concentrations with atopy and respiratory tract conditions. The mechanism that explains this association is still unclear. It has been suggested that this mechanism is due to the effects of vitamin D status on the regulation of the immune system.
The vitamin D receptor is expressed in various cells of the immune system, such as macrophages, monocytes, dendritic cells, and natural killer cells, as well as in B and T lymphocytes. Binding of the active form of vitamin D to its receptor leads to an increase in immunomodulatory activity that maintains the balance between the cellular immune response (Th1) and the humoral response (Th2), in addition to stimulating regulatory T cells.
Hypomagnesaemia (serum Mg level <0.74 mmol.L-1) has been also suggested to be associated with increased incidence of wheeze, airway hyperreactivity, and impairment of lung function. The mechanisms of action of magnesium (Mg) on respiratory airways are multiple and include relaxation of airways smooth muscle, bronchodilatation, anticholinergic effect, and stabilization of the mast cells
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- The study will include any child with three or more episodes of parentally reported wheeze aged from 1 month to less than 6 years admitted at pediatric department of Sohag University Hospital.
Key inclusion criteria (1 listed)
- Any child with three or more episodes of parentally reported wheeze aged from 1 month to less than 6 years admitted at pediatric department of Sohag University Hospital.
Key exclusion criteria (2 listed)
- patients with chronic lung and congenital heart diseases.
- Patients with body mass index (BMI) below 3rd percentile and those ≥ 85th percentile will be excluded to avoid effect of disturbed nutritional status on vitamin D level and occurrence of wheezing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Value of serum vitamin D, calcium and magnesium in infants and preschool recurrent wheezers
Time frame: One year
Serum vitamin D, calcium and magnesium venous blood sample (3ml) will be obtained from children with recurrent wheezes aged from 1 month to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 32432064Douros K, Everard ML. Time to Say Goodbye to Bronchiolitis, Viral Wheeze, Reactive Airways Disease, Wheeze Bronchitis and All That. Front Pediatr. 2020 May 5;8:218. doi: 10.3389/fped.2020.00218. eCollection 2020.
- Background: PubMed 16740815Ly NP, Gold DR, Weiss ST, Celedon JC. Recurrent wheeze in early childhood and asthma among children at risk for atopy. Pediatrics. 2006 Jun;117(6):e1132-8. doi: 10.1542/peds.2005-2271.
- Background: PubMed 27143615de Sousa RB, Medeiros D, Sarinho E, Rizzo JA, Silva AR, Bianca AC. Risk factors for recurrent wheezing in infants: a case-control study. Rev Saude Publica. 2016;50:15. doi: 10.1590/S1518-8787.2016050005100. Epub 2016 May 3.
- Background: PubMed 27401310Yang HK, Choi J, Kim WK, Lee SY, Park YM, Han MY, Kim HY, Hahm MI, Chae Y, Lee KJ, Kwon HJ, Ahn K, Kim J. The association between hypovitaminosis D and pediatric allergic diseases: A Korean nationwide population-based study. Allergy Asthma Proc. 2016 Jul;37(4):64-9. doi: 10.2500/aap.2016.37.3957.
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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.
Mostafa M Abosdera, Prodessor contact
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 Recurrent Wheezes, run by Sohag 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 2 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 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar A Ahmed, Resident (01018411770, Samr011103@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of serum vitamin D, calcium and magnesium in infants and preschool recurrent wheezers (time frame: One 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 NCT05040269, which also lists 4 linked publications.
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 Sep 2021.