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Completed

NCT Number: NCT01287455

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

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.

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Key information

Conditions

Asthma Avitaminosis Bronchial Diseases Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Vitamin D Deficiency

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAMBAM Health Care Campus

Haifa, Israel, 31096

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 as "BABY D3"

Drug

drops, 70 drops (= 14000 units), once weekly for 6 weeks

Placebo

Other

drops, 70 placebo drops, once weekly for 6 weeks

Primary outcomes

  1. Metacholine Challenge Test

    Time frame: study visit 1,3 (6wks- 3 months)

    As assessed by methacholine challenge test with determination of PC20.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2011
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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