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Vitamin D Deficiency and Asthma Exacerbation (AVD)

Primary Purpose

Asthma, Vitamin D Deficiency, Disease Exacerbation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral cholecalciferol
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, vitamin D, exacerbations, airway obstruction

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our Respiratory Clinic during the period October 2012-March 2013 and who had at least one year regular follow-up every three months

Exclusion Criteria:

  • Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    asthma severity and disease exacerbation

    Arm Description

    intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year

    Outcomes

    Primary Outcome Measures

    Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
    119 consecutive asthmatic patients underwent serum vitamin D (25-OHD) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on disease exacerbations during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and number of exacerbation was investigated
    Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
    55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Number of exacerbations were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency

    Secondary Outcome Measures

    Relationship between serum 25-OH vitamin D level and airway obstruction (evaluated by spirometry: one second forced expiratory volume, FEV1 l/sec, vital capacity (VC) and FEV1/VC%)
    119 consecutive asthmatic patients underwent serum vitamin D (25-OHD, ng/ml) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on lung function tests (forced expiratory volume in 1 second, FEV1, and vital capacity, VC) during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and airway obstruction (FEV1 and FEV1/VC%) was investigated
    Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on airway obstruction ( FEV1 l/sec, FEV1/VC%)
    55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Lung function tests (FEV1, VC and FEV1/VC%) were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency

    Full Information

    First Posted
    December 21, 2015
    Last Updated
    January 18, 2016
    Sponsor
    University of Turin, Italy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02661191
    Brief Title
    Vitamin D Deficiency and Asthma Exacerbation
    Acronym
    AVD
    Official Title
    Effect of Vitamin D Repletion on Asthma Exacerbation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Turin, Italy

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aim is in two phases. First phase: to evaluate the influence of vitamin D deficiency on asthma severity, degree of airway obstruction and frequency of asthma exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease exacerbations.
    Detailed Description
    The first phase of the study consisted of a cross-sectional examination of a cohort of 119 asthmatic patients, who had at least one year regular follow-up in our respiratory clinic, and were not receiving any vitamin D supplementation. In the second phase patients with vitamin D deficiency (25-OH D values below 20 ng/ml), were recruited in a one year longitudinal study, during which they received vitamin D supplementation. The study started and ended in late autumn-winter season when, at our latitude, sun exposure is lowest. Symptoms, spirometry and number of exacerbations were recorded during both study phases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Vitamin D Deficiency, Disease Exacerbation
    Keywords
    asthma, vitamin D, exacerbations, airway obstruction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    119 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    asthma severity and disease exacerbation
    Arm Type
    Other
    Arm Description
    intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year
    Intervention Type
    Drug
    Intervention Name(s)
    oral cholecalciferol
    Other Intervention Name(s)
    intramuscular cholecalciferol
    Intervention Description
    Inhaled corticosteroids and long-acting beta-agonists, salbutamol
    Primary Outcome Measure Information:
    Title
    Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
    Description
    119 consecutive asthmatic patients underwent serum vitamin D (25-OHD) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on disease exacerbations during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and number of exacerbation was investigated
    Time Frame
    one year
    Title
    Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
    Description
    55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Number of exacerbations were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Relationship between serum 25-OH vitamin D level and airway obstruction (evaluated by spirometry: one second forced expiratory volume, FEV1 l/sec, vital capacity (VC) and FEV1/VC%)
    Description
    119 consecutive asthmatic patients underwent serum vitamin D (25-OHD, ng/ml) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on lung function tests (forced expiratory volume in 1 second, FEV1, and vital capacity, VC) during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and airway obstruction (FEV1 and FEV1/VC%) was investigated
    Time Frame
    one year
    Title
    Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on airway obstruction ( FEV1 l/sec, FEV1/VC%)
    Description
    55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Lung function tests (FEV1, VC and FEV1/VC%) were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our Respiratory Clinic during the period October 2012-March 2013 and who had at least one year regular follow-up every three months Exclusion Criteria: Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caterina B Bucca, MD
    Organizational Affiliation
    Dept. Medical Science, University of Turin
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25496239
    Citation
    Malinovschi A, Masoero M, Bellocchia M, Ciuffreda A, Solidoro P, Mattei A, Mercante L, Heffler E, Rolla G, Bucca C. Severe vitamin D deficiency is associated with frequent exacerbations and hospitalization in COPD patients. Respir Res. 2014 Dec 13;15(1):131. doi: 10.1186/s12931-014-0131-0.
    Results Reference
    background
    PubMed Identifier
    24843804
    Citation
    Masoero M, Bellocchia M, Ciuffreda A, Ricciardolo FL, Rolla G, Bucca C. Laryngeal spasm mimicking asthma and vitamin d deficiency. Allergy Asthma Immunol Res. 2014 May;6(3):267-9. doi: 10.4168/aair.2014.6.3.267. Epub 2014 Jan 14.
    Results Reference
    background

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