Asthma in the Elderly: A Study of Choline Supplementation

Phase 3

Completed

• Conditions: Asthma in the Elderly
• Interventions: Dietary Supplement: Choline; Other: Placebo

• Registration Number: NCT02371993
• Lead Sponsor: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	See above
Choline 650 mg twice daily	Choline	See above
Choline 650 mg twice daily	Placebo	See above
Placebo	Choline	See above

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of choline supplementation on peripheral blood eosinophils	six weeks
Effect of choline supplementation on serum homocysteine levels	six weeks
Effect of choline supplementation on serum IgE	six weeks

Trial Locations

Locations (1)

Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.; 🇺🇸 Bryn Mawr, Pennsylvania, United States