NCT01248065

Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma

Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Vitamin D3	vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
DRUG	Ciclesonide	Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-11-25
• Last updated: 2014-08-13
• Results posted: 2014-08-13

Locations

16 sites across 1 country: United States