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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4
Given PO
Correlative studies
Given PO
Given PO
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
75% will be considered a success.
Time frame: At 12 months
Inspiratory muscle strength assessed by respiratory capacity (RPCI/UB study)
Will be analyzed using linear mixed model by regressing the repeated outcome on the group indicator (treatment or control) and other appropriate covariates. Appropriate within-subject covariance will be determined from an exploratory study. The effect of vitamin D3 supplementation will be tested using an approximate t-test.
Time frame: Baseline to 24 weeks
Change in exercise capacity assessed by respiratory exercise tests (RPCI/UB study)
Peak oxygen consumption will be used to establish cardiovascular fitness. Breath-by-breath measurements of minute ventilation, tidal volume, breathing frequency, end tidal carbon dioxide, carbon dioxide production and oxygen consumption will be continuously measured.
Time frame: Baseline to 24 weeks
Change in peripheral muscle strength assessed by the elbow flexion test (RPCI/UB study)
The elbow flexion test (upper extremity) requires participants to curl a standard 8 lb weight as many times as possible in a 30 second time period.
Time frame: Baseline to 24 weeks
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Efficacy in in COPD patients who are current versus former smokers will be compared.
Time frame: At 3 months
Conversion rate, defined as the proportion of patients whose baseline cholecalciferol deficiency is corrected (UPCI study)
Efficacy in in COPD patients who are current versus former smokers will be compared.
Time frame: At 6 months
Change in peripheral muscle strength assessed by squat test (RPCI/UB study)
This functional sit-to-stand test measures lower extremity strength. Participants will perform as many sit-to-stand repetitions from a standard height chair in 60 seconds as possible.
Time frame: Baseline to 24 weeks
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