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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01287455
First received: January 30, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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 Intervention
Asthma
Vitamin D Deficiency
Drug: Vitamin D3 as "BABY D3"
Other: placebo

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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Metacholine Challenge Test [ Time Frame: study visit 1,3 (6wks- 3 months) ] [ Designated as safety issue: Yes ]
    As assessed by methacholine challenge test with determination of PC20.


Secondary Outcome Measures:
  • IGE [ Time Frame: study visit 1,3 (6wks- 3 months) ] [ Designated as safety issue: No ]
    in peripheral Blood count

  • CBC [ Time Frame: study visit 1,3 (6wks- 3 months) ] [ Designated as safety issue: No ]
    in peripheral Blood count

  • Fractional Exhaled NO [ Time Frame: visit study 2,3 (6wks) ] [ Designated as safety issue: No ]
    determination of exhaled NO in Exhaled breath

  • skin tests for inhaled allergens [ Time Frame: visit study 2,3 (6wks) ] [ Designated as safety issue: No ]
  • Exhaled breath condensate [ Time Frame: visit study 2,3 (6wks) ] [ Designated as safety issue: No ]
    R-tubes test


Enrollment: 83
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287455

Locations
Israel
RAMBAM Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Lea Bentur, Prof. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01287455     History of Changes
Other Study ID Numbers: 483 CTIL, Vitamin D
Study First Received: January 30, 2011
Last Updated: June 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Asthma
Vitamin D
airway reactivity
metacholine challenge test

Additional relevant MeSH terms:
Asthma
Vitamin D Deficiency
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014