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

NCT01287455 | Completed

• 2 other identifiers: 483 CTILVitamin D
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Vitamin D Deficiency

Keywords

Asthma; Vitamin D; airway reactivity; metacholine challenge test

Outcome Measures

Primary Outcomes (1)

• Metacholine Challenge Test

  As assessed by methacholine challenge test with determination of PC20.

  study visit 1,3 (6wks- 3 months)

Secondary Outcomes (5)

• IGE

  study visit 1,3 (6wks- 3 months)

• CBC

  study visit 1,3 (6wks- 3 months)

• Fractional Exhaled NO

  visit study 2,3 (6wks)

• skin tests for inhaled allergens

  visit study 2,3 (6wks)

• Exhaled breath condensate

  visit study 2,3 (6wks)

Study Arms (2)

vitamin D

ACTIVE COMPARATOR

vitamin D deficient asthmatic patients receiving vitamin D supplement

Drug: Vitamin D3 as "BABY D3"

placebo

PLACEBO COMPARATOR

vitamin D deficient asthmatic patients receiving placebo

Other: placebo

Interventions

Vitamin D3 as "BABY D3" DRUG

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

vitamin D

placebo OTHER

drops, 70 placebo drops, once weekly for 6 weeks

placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years
• Mild-moderate asthma
• No anti inflammatory treatment over the past 2 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

RAMBAM Health Care Campus

Haifa, Israel, 31096, Israel

Location

Related Publications (1)

• Dabbah H, Bar Yoseph R, Livnat G, Hakim F, Bentur L. Bronchial Reactivity, Inflammatory and Allergic Parameters, and Vitamin D Levels in Children With Asthma. Respir Care. 2015 Aug;60(8):1157-63. doi: 10.4187/respcare.03763. Epub 2015 Apr 21.

  PMID: 25899478 DERIVED

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Lea Bentur, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2011
• First Posted: February 1, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

IL (1)