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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:
ClinicalTrials.gov Identifier:
NCT01287455
First Posted: February 1, 2011
Last Update Posted: June 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  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: Triple (Participant, Care Provider, 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) ]
    As assessed by methacholine challenge test with determination of PC20.


Secondary Outcome Measures:
  • IGE [ Time Frame: study visit 1,3 (6wks- 3 months) ]
    in peripheral Blood count

  • CBC [ Time Frame: study visit 1,3 (6wks- 3 months) ]
    in peripheral Blood count

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

  • skin tests for inhaled allergens [ Time Frame: visit study 2,3 (6wks) ]
  • Exhaled breath condensate [ Time Frame: visit study 2,3 (6wks) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01287455     History of Changes
Other Study ID Numbers: 483 CTIL
Vitamin D
First Submitted: January 30, 2011
First Posted: February 1, 2011
Last Update Posted: June 13, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents