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Asthma in the Elderly: The Role of Vitamin D

This study has been completed.
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: September 8, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 30
Study Start Date: November 2012
Study Completion Date: March 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: September 8, 2014
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014