Vitamin D to Prevent Severe Asthma Exacerbations (Vit-D-Kids Asthma)

• Status: Terminated
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan Celedon, MD; University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Pharmavite; Pharmavite LLC
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 6 to 16 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

Exclusion Criteria:

• Serum calcium >10.8 mg/dl

• Serum 25(OH) D <14 ng/ml (35 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 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