Asthma in the Elderly: A Study of Choline Supplementation

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

Status and phase: Completed; Phase 3

Conditions: Asthma in the Elderly

Treatments: Other: Placebo; Dietary Supplement: Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT02371993

F/N-R15-3427B

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Choline 650 mg twice daily

Experimental group

Description:

See above

Treatment:

Other: Placebo

Dietary Supplement: Choline

Placebo

Placebo Comparator group

Description:

See above

Treatment:

Other: Placebo

Dietary Supplement: Choline