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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01287455
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Vitamin D Deficiency	Drug: Vitamin D3 as "BABY D3"; Other: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vitamin D vitamin D deficient asthmatic patients receiving vitamin D supplement	Drug: Vitamin D3 as "BABY D3"; drops, 70 drops (= 14000 units), once weekly for 6 weeks
Placebo Comparator: placebo vitamin D deficient asthmatic patients receiving placebo	Other: placebo; drops, 70 placebo drops, once weekly for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Metacholine Challenge Test [study visit 1,3 (6wks- 3 months)]

   As assessed by methacholine challenge test with determination of PC20.

Secondary Outcome Measures

1. IGE [study visit 1,3 (6wks- 3 months)]

   in peripheral Blood count

2. CBC [study visit 1,3 (6wks- 3 months)]

   in peripheral Blood count

3. Fractional Exhaled NO [visit study 2,3 (6wks)]

   determination of exhaled NO in Exhaled breath

4. skin tests for inhaled allergens [visit study 2,3 (6wks)]

5. Exhaled breath condensate [visit study 2,3 (6wks)]

   R-tubes test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAMBAM Health Care Campus	Haifa		Israel	31096

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

• Principal Investigator: Lea Bentur, Prof., Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT01287455
• Other Study ID Numbers: 483 CTIL; Vitamin D
• First Posted: Feb 1, 2011
• Last Update Posted: Jun 13, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Rambam Health Care Campus: Asthma; Vitamin D; airway reactivity; metacholine challenge test
• Additional relevant MeSH terms: Vitamin D Deficiency; Vitamin D; Cholecalciferol

Study Results

No Results Posted as of Jun 13, 2013