NCT01730976

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

November 15, 2012

Last Update Submit

September 8, 2014

Conditions

Asthma in the Elderly

Keywords

asthma, elderly, vitamin D

Outcome Measures

Primary Outcomes (1)

  • Improvement in Asthma Control Test (ACT) score

    Three months

Secondary Outcomes (1)

  • Improvement in pulmonary function tests values (FEV1%, etc.)

    Three months

Other Outcomes (1)

  • Serum vitamin D and calcium levels

    Three months

Study Arms (1)

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

Vitamin D 2,000 I.U.DIETARY_SUPPLEMENT
Also known as: Vitamin Shoppe
Vitamin D 2,000 I.U. daily

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Asthma, age of 65 years old or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rohr and Columbo Asthma, Allergy and Immunology Specialists

Bryn Mawr, Pennsylvania, 19010, United States

Location

Related Publications (1)

  • 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.

    PMID: 25221606DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Michele Columbo, M.D.

    Rohr and Columbo Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations

US(1)