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Summary

Eligibility
for people ages 6–14
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

This study will determine whether vitamin D3 prevents severe asthma attacks in children who have a serum vitamin D (25(OH)D) level <30 ng/ml and who are being treated with inhaled corticosteroids for asthma. Half the participants will receive vitamin D3 at a dose of 4,000 IU/day, and the other half will receive placebo.

Official Title

Vitamin D to Prevent Severe Asthma Exacerbations

Details

Results from experimental studies, observational studies, and two small trials suggest that vitamin D reduces the risk of severe asthma exacerbations, and that this protective effect may be due to immune modulation of viral illnesses and/or increased response to inhaled corticosteroids (ICS).

On the basis of those findings, the investigators hypothesize that vitamin D reduces the incidence of severe asthma exacerbations in high-risk school-aged children who have a serum vitamin D level <30 ng/ml and who are being treated with ICS for persistent asthma. The investigators further hypothesize that this protective effect results from reduced incidence of common viral illnesses or enhanced response to ICS. These hypotheses will be tested in a 48-week randomized double-masked placebo-controlled trial of vitamin D3 supplementation to prevent severe asthma exacerbations in 400 children aged 6 to 14 years who have vitamin D insufficiency or deficiency (a serum 25(OH)D <30 ng/ml) and experienced a severe exacerbation in the prior year (a marker of high risk for subsequent events), and who (after a run-in period) are well controlled on medium-dose inhaled corticosteroids.

Our primary aim will determine whether vitamin D3 (4,000 IU/day) reduces the risk of severe asthma exacerbations (our primary outcome) in participating children. Secondary aims will determine the efficacy of vitamin D3 supplementation in: 1) preventing severe asthma exacerbations due to viral infections, 2) reducing the daily and average cumulative dose of inhaled corticosteroids.

Keywords

Asthma Vitamin D, severe asthma exacerbations, children Vitamins Vitamin D Ergocalciferols Cholecalciferol

Eligibility

You can join if…

Open to people ages 6–14

  • 6 to 14 years old
  • Physician-diagnosed asthma for at least one year
  • At least one severe asthma exacerbation in the previous year
  • Use of asthma medications (daily controller medication [ICS or leukotriene inhibitor]or inhaled β2-agonist [at least three days per week]) for at least six months in the previous year
  • Vitamin D insufficiency (i.e., serum vitamin D (25(OH)D level <30 ng/ml (75 nmol/L))
  • FEV1 ≥70 % of predicted
  • Positive bronchodilator response (i.e., increase in FEV1 ≥8% from baseline after inhaled short acting beta agonist or increased airway responsiveness to methacholine(PC20 ≤8 mg/ml if not on ICS or PC20 ≤16 mg/ml if on ICS)
  • Study protocol (i.e., age-appropriate dose of Fluticasone and no other asthma controller medications) approved by the child's regular doctor
  • Parental consent and child's assent to participate in the study.

    Additional inclusion criteria applied after the run-in period, to be eligible for randomization:

  • Adherence with ICS and study medication (≥75% use [at least 21 of 28 days]) during the run-in period
  • Willingness to be randomized and complete study

You CAN'T join if...

  • Serum calcium>10.8 mg/dl
  • Serum 25(OH) D <10 ng/ml (25 nmol/L)
  • Chronic respiratory disorder other than asthma
  • Severe asthma (intubation for asthma at any time OR ≥3 hospitalizations for asthma in previous year OR ≥6 severe asthma exacerbations in previous year)
  • Hepatic/renal disease, rickets, malabsorption, or other diseases that would affect vitamin D metabolism
  • Current smoking, or former smoking if ≥5 pack-years
  • Immune deficiency, cleft palate or Down's syndrome
  • Treatment with anticonvulsants or ≥1,000 IU/day of vitamin D2 or D3
  • Chronic oral corticosteroid therapy
  • Inability to perform acceptable spirometry
  • Use of investigational therapies or participation in trials 30 days before or during the study
  • Participant is currently breast feeding an infant
  • Pregnancy
  • Weight less than 10 kg
  • Plans to move out of the study site (Pittsburgh or San Francisco) area in the next year

Additional exclusion criteria applied after the run-in period:

  • Any severe asthma exacerbation during the run-in period
  • Need for asthma medications other than ICS and p.r.n. rescue inhalers during the run-in period

Locations

  • Saint Louis Children's Hospital accepting new patients
    Saint Louis, Missouri, 63110, United States
  • Children's Hospital of Pittsburgh of UPMC accepting new patients
    Pittsburgh, Pennsylvania, 15224, United States
  • Boston Children's Hospital accepting new patients
    Boston, Massachusetts, 02115, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pittsburgh
ID
NCT02687815
Phase
Phase 2
Study Type
Interventional
Last Updated
March 1, 2017