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The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alfacalcidol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients diagnosed with asthma
  2. Non-smokers

Exclusion Criteria:

  1. Liver impairment
  2. Kidney impairment
  3. Patients receiving digoxin
  4. Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives
  5. Hypercalcaemia
  6. Hyperphosphatemia
  7. Pregnancy and breast-feeding
  8. Patients on nutritional supplements with a potential effect on 25(OH)D serum concentrations
  9. Had a History of stones in the urinary tract or diseases of calcium or bone metabolism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention

    control

    Arm Description

    receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications

    Asthmatic patients receiving conventional asthma medications

    Outcomes

    Primary Outcome Measures

    forced expiratory volume % predicted values

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2016
    Last Updated
    April 20, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02747381
    Brief Title
    The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients
    Official Title
    The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on the the pulmonary function of adult asthmatic Egyptian patients
    Detailed Description
    Asthmatic patients are recruited and divided into two groups. One receives Alfacalcidol beside their normal medications while the other acts as a control group receiving the normal asthma medication. Both groups are followed up for four months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    Asthmatic patients receiving conventional asthma medications
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Alfacalcidol
    Other Intervention Name(s)
    One alpha
    Intervention Description
    1-alpha hydroxy cholecalciferol 1 mcg
    Primary Outcome Measure Information:
    Title
    forced expiratory volume % predicted values
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with asthma Non-smokers Exclusion Criteria: Liver impairment Kidney impairment Patients receiving digoxin Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives Hypercalcaemia Hyperphosphatemia Pregnancy and breast-feeding Patients on nutritional supplements with a potential effect on 25(OH)D serum concentrations Had a History of stones in the urinary tract or diseases of calcium or bone metabolism
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amani Ali
    Organizational Affiliation
    Faculty of pharmacy, Cairo university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28377173
    Citation
    Ali AM, Selim S, Abbassi MM, Sabry NA. Effect of alfacalcidol on the pulmonary function of adult asthmatic patients: A randomized trial. Ann Allergy Asthma Immunol. 2017 May;118(5):557-563. doi: 10.1016/j.anai.2017.02.014. Epub 2017 Apr 1.
    Results Reference
    derived

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    The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients

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