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

NCT01248065 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2014-08-13

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • David T. Mauger, PhD · Pennsylvania State University College of Medicine

  • Elliot Israel, MD · Brigham and Women's Hospital

  • Lewis Smith, MD · Northwestern Memorial Hospital

  • Julian Solway, MD · University of Chicago

  • James Moy, MD · Rush University Medical Center

  • Richard Martin, MD · National Jewish Health

  • Christine Sorkness, MD · University of Wisconsin, Madison

  • Elizabeth Bade, MD · Aurora Sinai Medical Center

  • Sally Wenzel, MD · University of Pittsburgh Medical Center

  • James Chmiel, MD · Case Western Reserve University School of Medicine

  • Mario Castro, MD · Washington University School of Medicine

  • Homer Boushey, MD · University of California, San Francisco

  • Monica Kraft, MD · Duke University

  • Stephen Peters, MD · Wake Forest University Health Sciences

  • W. Gerald Teague, MD · University of Virginia Health System

  • Craig LaForce, MD · North Carolina Clinical Research

  • Anne Fitzpatrick, MD · Emory University

  • Jerry Krishnan, MD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248065 on ClinicalTrials.gov