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Asthma in the Elderly: A Study of Choline Supplementation

Primary Purpose

Asthma in the Elderly

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Choline
Placebo
Sponsored by
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in the Elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asthma

Exclusion Criteria:

  • No history of smoking more than 10 pack/years,
  • no gastrointestinal cancers,
  • no liver or kidney disease,
  • no bipolar disorder.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Choline 650 mg twice daily

Placebo

Arm Description

See above

See above

Outcomes

Primary Outcome Measures

Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)

Secondary Outcome Measures

Effect of choline supplementation on peripheral blood eosinophils
Effect of choline supplementation on serum IgE
Effect of choline supplementation on serum homocysteine levels

Full Information

First Posted
February 10, 2015
Last Updated
October 28, 2015
Sponsor
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT02371993
Brief Title
Asthma in the Elderly: A Study of Choline Supplementation
Official Title
Asthma in the Elderly: A Study of Choline Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in the Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Choline 650 mg twice daily
Arm Type
Experimental
Arm Description
See above
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
See above
Intervention Type
Dietary Supplement
Intervention Name(s)
Choline
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
Time Frame
six weeks
Title
Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Effect of choline supplementation on peripheral blood eosinophils
Time Frame
six weeks
Title
Effect of choline supplementation on serum IgE
Time Frame
six weeks
Title
Effect of choline supplementation on serum homocysteine levels
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma Exclusion Criteria: No history of smoking more than 10 pack/years, no gastrointestinal cancers, no liver or kidney disease, no bipolar disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Columbo, M.D.
Organizational Affiliation
Rohr and Columbo Asthma, Allergy and Immunology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26973701
Citation
Columbo M, Rohr AS. Asthma in the elderly: the effect of choline supplementation. Allergy Asthma Clin Immunol. 2016 Mar 11;12:15. doi: 10.1186/s13223-016-0121-5. eCollection 2016.
Results Reference
derived

Learn more about this trial

Asthma in the Elderly: A Study of Choline Supplementation

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