Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients
This phase IIb randomized trial studies how well cholecalciferol (vitamin D3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (COPD). Cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with COPD.
PRIMARY OBJECTIVES:
I. To establish the effect of D vitamin (vitamin D3) supplementation on inspiratory muscle
strength in vitamin D3-deficient chronic obstructive pulmonary disease (COPD) patients.
(Roswell Park Cancer Institute [RPCI]/University at Buffalo [UB] study) II. To establish the
12 month conversion rate. (University of Pittsburgh Cancer Institute [UPCI] study)
SECONDARY OBJECTIVES:
I. To establish the effect of vitamin D3 supplementation on peripheral muscle strength and
exercise capacity in vitamin D3-deficient COPD patients. (RPCI/UB study) II. To establish
the 3 and 6-month conversion rates. (UPCI study) III. To examine whether vitamin D3
supplementation is equally effective in COPD patients who are current versus former smokers.
(UPCI study)
TERTIARY OBJECTIVES:
I. To explore the effects of vitamin D3 supplementation in COPD patients on biomarkers of
lung cancer risk, inflammation, and pulmonary function. (UPCI study)
OUTLINE: Patients are randomized to 1 of 2 arms.
CONTROL ARM: Patients receive a placebo and multivitamin orally (PO) once daily (QD) for 52
weeks.
SUPPLEMENTATION ARM: Patients receive a multivitamin and cholecalciferol supplement PO QD
for 52 weeks.
After completion of study treatment, patients are followed up for 1 year.
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