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Completed

NCT Number: NCT02371993

Asthma in the Elderly: A Study of Choline Supplementation

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Bryn Mawr, Pennsylvania, 19010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Choline

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test

    Time frame: six weeks

  2. Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)

    Time frame: six weeks

Secondary outcomes

  1. Effect of choline supplementation on peripheral blood eosinophils

    Time frame: six weeks

  2. Effect of choline supplementation on serum IgE

    Time frame: six weeks

  3. Effect of choline supplementation on serum homocysteine levels

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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