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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

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ClinicalTrials.gov Identifier: NCT01287455
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Study Start Date : February 2011
Primary Completion Date : February 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

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



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

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

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

  4. skin tests for inhaled allergens [ Time Frame: visit study 2,3 (6wks) ]
  5. Exhaled breath condensate [ Time Frame: visit study 2,3 (6wks) ]
    R-tubes test



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

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

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 Posted: February 1, 2011    Key Record Dates
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