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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014