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Trial of Vitamin D3 Supplementation in Paediatric Asthma (NCHVitDAst)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
VItamin D3
Sponsored by
Conor Kerley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous clinical diagnosis of asthma
  • Ability to perform pulmonary function tests
  • Established on anti-asthmatic pharmacotherapy with no expected change

Exclusion Criteria:

  • Use of medications that influence vitamin D metabolism or absorption
  • Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Placebo

    Arm Description

    2,000iu vitamin D3 per day for 15 weeks

    An identical placebo capsule daily for 15 weeks.

    Outcomes

    Primary Outcome Measures

    Paediatic Asthma Control Test (P-ACT)

    Secondary Outcome Measures

    Global Initiative for Asthma Score
    Pulmonary function
    FEV1, FVC, FEV1:FVC
    Height velocity
    Rate of change in height
    Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.
    Mini paediatric asthma quality of life questionnaire
    Asthma Diary
    A 13 item diary to be filled out weekly by parents/gaurdians.

    Full Information

    First Posted
    October 10, 2014
    Last Updated
    December 1, 2015
    Sponsor
    Conor Kerley
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02428322
    Brief Title
    Trial of Vitamin D3 Supplementation in Paediatric Asthma
    Acronym
    NCHVitDAst
    Official Title
    Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Conor Kerley

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.
    Detailed Description
    Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.

    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
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    2,000iu vitamin D3 per day for 15 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    An identical placebo capsule daily for 15 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    VItamin D3
    Intervention Description
    Soft gel capsules will contain 2,000IU vitamin D.
    Primary Outcome Measure Information:
    Title
    Paediatic Asthma Control Test (P-ACT)
    Time Frame
    15 weeks
    Secondary Outcome Measure Information:
    Title
    Global Initiative for Asthma Score
    Time Frame
    15 weeks
    Title
    Pulmonary function
    Description
    FEV1, FVC, FEV1:FVC
    Time Frame
    15 weeks
    Title
    Height velocity
    Description
    Rate of change in height
    Time Frame
    15 weeks
    Title
    Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.
    Time Frame
    15 weeks
    Title
    Mini paediatric asthma quality of life questionnaire
    Time Frame
    15 weeks
    Title
    Asthma Diary
    Description
    A 13 item diary to be filled out weekly by parents/gaurdians.
    Time Frame
    15 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Previous clinical diagnosis of asthma Ability to perform pulmonary function tests Established on anti-asthmatic pharmacotherapy with no expected change Exclusion Criteria: Use of medications that influence vitamin D metabolism or absorption Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Basil Elnazir, MD
    Organizational Affiliation
    National Children's Hospital, Dublin 24, Ireland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Trial of Vitamin D3 Supplementation in Paediatric Asthma

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