Asthma in the Elderly: The Role of Vitamin D

September 8, 2014 updated by: Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Rohr and Columbo Asthma, Allergy and Immunology Specialists

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asthma, age of 65 years old or older

Exclusion Criteria:

  • Current smokers, subjects who smoked more than 10 pack/year, subjects taking digoxin, subjects with liver disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D 2,000 I.U. daily
Study subjects will take 2,000 I.U. vitamin D daily for three months
Dietary supplement: Vitamin D 2,000 I.U.
Other Names:
  • Vitamin Shoppe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Asthma Control Test (ACT) score
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in pulmonary function tests values (FEV1%, etc.)
Time Frame: Three months
Three months

Other Outcome Measures

Outcome Measure
Time Frame
Serum vitamin D and calcium levels
Time Frame: Three months
Three months

Collaborators and Investigators

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

Sponsor

Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Investigators

  • Principal Investigator: Michele Columbo, M.D., Rohr and Columbo Associates

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

November 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/N-R13-3217B
  • SSRF2012-01 (Other Grant/Funding Number: SSRF2012-01)

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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