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

Asthma Clinical Trial

— VIDA  

Official title:

Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248065
• Other study ID #: AsthmaNet 001
• Secondary ID: 1U10HL098115
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2010
• Last updated: July 23, 2014
• Start date: April 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women 18 years of age and older

• Physician-diagnosed asthma for at least previous 12 months

• Asthma confirmed by: (a) ß-agonist reversibility of forced expiratory volume in 1 second (FEV1) =12 % following 180 mcg (4 puffs) levalbuterol at visit 1 OR (b) methacholine provocative concentration causing a 20% fall in FEV1 (PC20) = 8 mg/ml if not receiving an inhaled corticosteroid or = 16 mg/ml if receiving an inhaled corticosteroid at visit 2. Source documentation for PC20 from an AsthmaNet methacholine challenge completed within 6 months of visit 2 will be accepted.

• Stable asthma controller therapy (inhaled corticosteroid or leukotriene modifier only) dose for past 2 weeks

• FEV1 = 50% of predicted at visit 1

• Vitamin D level of less than 30 ng/ml at visit 0

• Experienced no more than one treatment failure in the VIDA run-in or oral corticosteroid (OCS) response periods on previous enrollments

• For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study

Exclusion Criteria:

• Taking vitamin D supplements containing > 1000 IU/day of vitamin D

• Taking >2500 mg/day calcium supplements

• Chronic oral corticosteroid therapy

• Chronic inhaled corticosteroid therapy > 1,000 mcg of fluticasone daily or the equivalent

• History of physician-diagnosed nephrolithiasis

• Use of concomitant medications that alter vitamin D metabolism - phenytoin, phenobarbital, cardiac glycosides; or absorption - orlistat, cholestyramine, colestipol; or those that interfere with study endpoints

• Impaired renal function (GFR < 30 ml/min)

• Asthma exacerbation within past 4 weeks requiring systemic corticosteroids

• Respiratory tract infection within past 4 weeks

• Chronic diseases (other than asthma)

• History of cigarette smoking within the past 1 year or > 10 pack years total

• Serum calcium greater than 10.2 mg/dl on entry

• Urine calcium/creatinine ratio greater than 0.37 (urinary Ca and Creat in mg)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center/Stroger Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University School of Medicine	Durham	North Carolina
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	University of California - San Francisco	San Francisco	California
United States	Washington University	St. Louis	Missouri
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure	Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.	Twenty-eight week intervention period from randomization until end of trial.	No
Secondary	Lung Function Change From Baseline	FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.	Change is measured as value at 28 weeks minus baseline value.	No
Secondary	Exacerbations	Outcome defined as number of exacerbations per person-year.	Overall exacerbation rate during 28-week trial	No