The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287455
• Other study ID #: 483 CTIL
• Secondary ID: Vitamin D
• Status: Completed
• Phase: N/A
• First received: January 30, 2011
• Last updated: June 12, 2013
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Research Title: The effect of vitamin D replacement on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 6-18 years

• Mild-moderate asthma

• No anti inflammatory treatment over the past 2 weeks

Exclusion Criteria:

• Any Chronic Lung Disease

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Asthma
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3 as "BABY D3"
drops, 70 drops (= 14000 units), once weekly for 6 weeks

Other:
• placebo
drops, 70 placebo drops, once weekly for 6 weeks

Locations

Country	Name	City	State
Israel	RAMBAM Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metacholine Challenge Test	As assessed by methacholine challenge test with determination of PC20.	study visit 1,3 (6wks- 3 months)	Yes
Secondary	IGE	in peripheral Blood count	study visit 1,3 (6wks- 3 months)	No
Secondary	CBC	in peripheral Blood count	study visit 1,3 (6wks- 3 months)	No
Secondary	Fractional Exhaled NO	determination of exhaled NO in Exhaled breath	visit study 2,3 (6wks)	No
Secondary	skin tests for inhaled allergens		visit study 2,3 (6wks)	No
Secondary	Exhaled breath condensate	R-tubes test	visit study 2,3 (6wks)	No