This randomized phase IIb trial studies how cholecalciferol supplementation works in preventing lung cancer in patients with chronic obstructive pulmonary disease who have low levels of D vitamin. When added to the diet, cholecalciferol (also known as Vitamin D3) may increase blood levels of this form of D vitamin. Cholecalciferol may improve lung health and reduce the risk of developing infections in the lungs and possibly lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02532062.
PRIMARY OBJECTIVES:
I. To establish the 12-month conversion rate (i.e., proportion of subjects whose baseline vitamin D3 [cholecalciferol] deficiency is corrected after 12 months of supplementation).
SECONDARY OBJECTIVES:
I. To determine the 3-month and 6-month conversion rates.
II. To examine the effect of vitamin D3 supplementation in current and former smokers.
III. To examine the effects of vitamin D3 supplementation on biomarkers of lung cancer risk, inflammation, and pulmonary function.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a cholecalciferol pill orally (PO) and a multivitamin PO daily. Treatment continues for up to 52 weeks.
ARM II: Patients receive a placebo pill PO and a multivitamin PO daily. Treatment continues for up to 52 weeks.
After completion of study treatment, patients are followed up for 1 year.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorDavid Wilson
