Asthma in the Elderly: The Role of Vitamin D | NCT01730976

Studies
Asthma in the Elderly: The Role of Vitamin D

NCT01730976

Sponsor

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

Status

Completed

Last Update Posted

Sep 10, 2014Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Asthma in the Elderly

Interventions

Vitamin D 2,000 I.U.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SSRF2012-01	Other Grant/Funding Number	SSRF2012-01

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 15, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2014

Last Update Posted Date

Sep 10, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele Columbo, M.D., Principal Investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.Principal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D 2,000 I.U. daily	Experimental	Study subjects will take 2,000 I.U. vitamin D daily for three months	Dietary Supplement: Vitamin D 2,000 I.U.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D 2,000 I.U.	Dietary Supplement		Vitamin D 2,000 I.U. daily	Vitamin Shoppe

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Serum vitamin D and calcium levels		Three months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele Columbo, M.D.	Rohr and Columbo Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rohr and Columbo Asthma, Allergy and Immunology Specialists		Bryn Mawr	Pennsylvania	19010	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25221606	Derived	Columbo M, Panettieri RA Jr, Rohr AS. Asthma in the elderly: a study of the role of vitamin D. Allergy Asthma Clin Immunol. 2014 Sep 5;10(1):48. doi: 10.1186/1710-1492-10-48. eCollection 2014.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases