Conditions: Asthma
Keywords: Asthma Vitamin D Corticosteroids Treatment failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 408
Healthy volunteers: no

Brief summary:
The purpose of the study is to find out if taking vitamin D in addition to an asthma controller medication helps to prevent worsening of asthma symptoms and asthma attacks.

Detailed description:
This is a randomized, double-blind parallel group trial that will enroll individuals who have vitamin D insufficiency and asthma with persistent symptoms despite low-dose inhaled corticosteroid. Participants on low-dose inhaled corticosteroid will be randomized to add-on therapy with either placebo or high-dose vitamin D for a 28-week period. During the inhaled corticosteroid-stable phase, participants will remain on low-dose inhaled corticosteroid. During the inhaled corticosteroid-taper phase, participants will taper their inhaled corticosteroid by 50% at two time-points post-randomization. The investigators will determine if the addition of vitamin D reduces the likelihood of treatment failure when compared to placebo during both the inhaled corticosteroid-stable and inhaled corticosteroid-taper phases of the study. Given the high prevalence of both vitamin D insufficiency and asthma, this trial has high potential to impact daily asthma management.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Vitamin D3 intervention 2: Ciclesonide
Intervention descriptions: intervention 1: vitamin D (100,000 IU loading dose followed by 4,000 IU/day) intervention 2: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Protocol document: