The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children
NCT ID: NCT01287455
Last Updated: 2013-06-13
Study Results
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Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2011-02-28
2012-12-31
Brief Summary
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Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract and airway hyperreactivity.
Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children.
Design: Double blind placebo control prospective study comparing the effect of Vitamin D replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in asthmatic pediatric population with vitamin D deficiency.
Participant selection: The study group will consist of pediatric patients (age 6-18 years) followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.
Patients with mild-moderate asthma with low or insufficient vitamin D levels that are currently not receiving anti-inflammatory treatment will be recruited.
Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving placebo).
Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance preparation once weekly for 6 weeks between visit two and three.
Three visits will be conducted. Each subject will undergo evaluation including a respiratory questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2 and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC) (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1, 3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled allergens will be performed (visit 2, 3).
Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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vitamin D
vitamin D deficient asthmatic patients receiving vitamin D supplement
Vitamin D3 as "BABY D3"
drops, 70 drops (= 14000 units), once weekly for 6 weeks
placebo
vitamin D deficient asthmatic patients receiving placebo
placebo
drops, 70 placebo drops, once weekly for 6 weeks
Interventions
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Vitamin D3 as "BABY D3"
drops, 70 drops (= 14000 units), once weekly for 6 weeks
placebo
drops, 70 placebo drops, once weekly for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Mild-moderate asthma
* No anti inflammatory treatment over the past 2 weeks
Exclusion Criteria
* Febrile Illness in last 2 weeks
* FEV1 \< 65% in study day
* Bronchodilators over the past 24 hours prior to each study
* Participation in any other clinical studies over the past 4 weeks
6 Years
18 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Lea Bentur, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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RAMBAM Health Care Campus
Haifa, Israel, Israel
Countries
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References
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Dabbah H, Bar Yoseph R, Livnat G, Hakim F, Bentur L. Bronchial Reactivity, Inflammatory and Allergic Parameters, and Vitamin D Levels in Children With Asthma. Respir Care. 2015 Aug;60(8):1157-63. doi: 10.4187/respcare.03763. Epub 2015 Apr 21.
Other Identifiers
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Vitamin D
Identifier Type: -
Identifier Source: secondary_id
483 CTIL
Identifier Type: -
Identifier Source: org_study_id
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