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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02687815

Run by

Juan Celedon, MD

People needed

192

Starts

2016-02-22

Expected to finish

2019-09-17

Last updated by the study team

2021-08-12

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California - San Francisco — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Saint Louis Children's Hospital — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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