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

July 23, 2014 updated by: dave mauger, Milton S. Hershey Medical Center

Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center/Stroger Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Durham, North Carolina, United States, 27110
        • Duke University School of Medicine
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18 years of age and older
  • Physician-diagnosed asthma for at least previous 12 months
  • Asthma confirmed by: (a) β-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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Ciclesonide + placebo
Drug: Ciclesonide
Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
Other Names:
  • Alvesco®
Experimental: Ciclesonide + Vitamin D
Drug: Ciclesonide
Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
Other Names:
  • Alvesco®
Drug: Vitamin D3
vitamin D (100,000 IU loading dose followed by 4,000 IU/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Failure
Time Frame: Twenty-eight week intervention period from randomization until end of trial.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Function Change From Baseline
Time Frame: Change is measured as value at 28 weeks minus baseline value.
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.
Exacerbations
Time Frame: Overall exacerbation rate during 28-week trial
Outcome defined as number of exacerbations per person-year.
Overall exacerbation rate during 28-week trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Craig LaForce, MD, North Carolina Clinical Research
  • Principal Investigator: James Moy, MD, Rush University Medical Center
  • Principal Investigator: Elizabeth Bade, MD, Aurora Sinai Medical Center
  • Principal Investigator: James Chmiel, MD, Case Western Reserve University School of Medicine
  • Principal Investigator: W. Gerald Teague, MD, University of Virginia Health System
  • Principal Investigator: Anne Fitzpatrick, MD, Emory University
  • Principal Investigator: Jerry Krishnan, MD, University of Illinois at Chicago
  • Principal Investigator: David T. Mauger, PhD, Pennsylvania State University College of Medicine
  • Principal Investigator: Lewis Smith, MD, Northwestern Memorial Hospital
  • Principal Investigator: Julian Solway, MD, University of Chicago
  • Principal Investigator: Richard Martin, MD, National Jewish Health
  • Principal Investigator: Christine Sorkness, MD, University of Wisconsin, Madison
  • Principal Investigator: Sally Wenzel, MD, University of Pittsburgh Medical Center
  • Principal Investigator: Stephen Peters, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsthmaNet 001
  • 1U10HL098115 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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