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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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) |
- 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.
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated 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 |
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| Contact: Lea Bentur, Prof. | 972-4-854-3263 | l_bentur@rambam.health.gov.il |
| Israel | |
| RAMBAM Health Care Campus | Active, not recruiting |
| Haifa, Israel, 31096 | |
| Principal Investigator: | Lea Bentur, Prof. | Rambam Health Care Campus |
More Information
No publications provided
| Responsible Party: | Prof. Lea Bentur, 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: | January 31, 2011 |
| 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 May 21, 2013