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Asthma in the Elderly: The Role of Vitamin D

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
ClinicalTrials.gov Identifier:
NCT01730976
First received: November 15, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

We will study whether taking vitamin D improves asthma control and spirometric values in elderly asthmatics.


Condition Intervention Phase
Asthma in the Elderly
 Dietary Supplement: Vitamin D 2,000 I.U.
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Asthma in the Elderly: The Role of Vitamin D

Resource links provided by NLM:

MedlinePlus related topics: Asthma Vitamin D
U.S. FDA Resources

Further study details as provided by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.:

Primary Outcome Measures:
  • Improvement in Asthma Control Test (ACT) score [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in pulmonary function tests values (FEV1%, etc.) [ Time Frame: Three months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Serum vitamin D and calcium levels [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vitamin Shoppe

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730976

Locations
United States, Pennsylvania
Rohr and Columbo Asthma, Allergy and Immunology Specialists
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Investigators
Principal Investigator: Michele Columbo, M.D. Rohr and Columbo Associates
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michele Columbo, M.D., Principal Investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
ClinicalTrials.gov Identifier: NCT01730976     History of Changes
Other Study ID Numbers: F/N-R13-3217B, SSRF2012-01
Study First Received: November 15, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.:
asthma, elderly, vitamin D

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013