Serum Levels of Vitamin D,Calcium and Magnesium in Preschool Recurrent Wheezers

September 14, 2021 updated by: Samar Alsoudy Ahmed, Sohag University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mostafa M Abosdera, Prodessor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University
        • Contact:
          • Osama R Elsherf, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

August 22, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-07-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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