Lung Cancer Clinical Trial
Cholecalciferol Supplementation in Strengthening Inspiratory Muscles in Cholecalciferol-Deficient Patients With Chronic Obstructive Pulmonary Disease
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Current or ex-smoker with at least a 10-year pack history
COPD, defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 70% and FEV1% predicted < 80%
25-hydroxy vitamin D3 (25[OH]D3) level less than 20 ng/mL prior to study initiation
Willingness to comply with study guidelines
Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
Personal history of lung cancer or head and neck cancer
History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
History of known thyroid disease
History of known sarcoid disease
History of known abnormalities in calcium metabolism
Hypercalcemia (serum calcium in excess of laboratory upper limit normal [ULN])
Self-reported consumption of more than 4 alcoholic drinks per day
Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism
History of known renal dysfunction
History of known nephrolithiasis (kidney stones)
Current use of supplemental oxygen
Inability to exercise due to musculoskeletal issue, osteoarthritis or underlying cardiac disease
Current participation in a cancer intervention prevention study, except for smoking cessation
Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
Inability to swallow pills
Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment
Positive Pregnancy Test
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There is 1 Location for this study
Buffalo New York, 14263, United States
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