Asthma, Vitamin D Resistant Rickets
Conditions
Keywords
Rickets, Vitamin D, airway hyperreactivity, Exhaled breath condensate
Brief summary
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets. Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls. Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test. Secondary outcome parameters: All other parameters are the secondary end points.
Detailed description
Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets. Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D. Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate. Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls. Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test. Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits. Primary end point: Airway reactivity as assessed by methacholine challenge test. Secondary outcome parameters: All other parameters are the secondary end points.
Interventions
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Sponsors
Rambam Health Care Campus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Vitamin D Resistent Rickets * Age between 3 - 40 years
Exclusion criteria
* Any Chronic Lung Disease * Febrile Illness in last 2 weeks * Inhaled Corticosteroids over the past 2 weeks * Bronchodilators over the past 24 hours * Participation in any other clinical studies over the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metacholine Challenge Test | participants will be followed for the duration of hospital visit, an average of 3 hours | As assessed by methacholine challenge test with determination of PC20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CBC | participants will be followed for the duration of hospital visit, an average of 3 hours | in peripheral Blood count |
| Fractional Exhaled NO | participants will be followed for the duration of hospital visit, an average of 3 hours | determination of exhaled NO in Exhaled breath |
| skin tests for inhaled allergens | participants will be followed for the duration of hospital visit, an average of 3 hours | — |
| IgE | participants will be followed for the duration of hospital visit, an average of 3 hours | in peripheral Blood count |
| C reactive protein | participants will be followed for the duration of hospital visit, an average of 3 hours | in peripheral Blood count |
| 25 OH vitamin D3 | participants will be followed for the duration of hospital visit, an average of 3 hours | in peripheral Blood count |
| Inhaled breath condensate | participants will be followed for the duration of hospital visit, an average of 3 hours | — |
Countries
Israel
Outcome results
None listed