Asthma in the Elderly: A Study of Choline Supplementation

October 28, 2015 updated by: Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choline 650 mg twice daily
See above
Other: Placebo
Dietary supplement: Choline
Placebo Comparator: Placebo
See above
Other: Placebo
Dietary supplement: Choline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
Time Frame: six weeks
six weeks
Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of choline supplementation on peripheral blood eosinophils
Time Frame: six weeks
six weeks
Effect of choline supplementation on serum IgE
Time Frame: six weeks
six weeks
Effect of choline supplementation on serum homocysteine levels
Time Frame: six weeks
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/N-R15-3427B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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