Asthma in the Elderly: A Study of Choline Supplementation

NCT ID: NCT02371993

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma in the Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Choline 650 mg twice daily

See above

Group Type EXPERIMENTAL

Choline

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Placebo

See above

Group Type PLACEBO_COMPARATOR

Choline

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Interventions

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Choline

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Michele Columbo, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Columbo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rohr and Columbo Asthma, Allergy and Immunology Specialists

Locations

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

Bryn Mawr, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26973701 (View on PubMed)

Other Identifiers

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F/N-R15-3427B

Identifier Type: -

Identifier Source: org_study_id

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