The Pittsburgh Vitamin D Study: Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer
NCT02532062 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2018-06-26
Summary
This study aims to establish the ability of 4,000 IU oral vitamin D3 per day (in combination with a daily multivitamin) to safely convert vitamin D3-deficient subjects at increased risk of lung cancer to a vitamin D3-sufficient state, and to explore effects of vitamin D3 supplementation in this population on markers of inflammation and lung cancer risk. Current and former smokers with chronic obstructive pulmonary disease (COPD) are at increased risk of developing lung cancer and represent the clinical population of interest for this study.
Conditions
- Deficiency of Vitamin D3
- COPD
Interventions
- DIETARY_SUPPLEMENT
-
Cholecalciferol
4,000 IU, oral, once a day for one year
- DIETARY_SUPPLEMENT
-
multivitamin
oral, once a day for one year
- DIETARY_SUPPLEMENT
-
Placebo
oral, once a day for one year
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Pittsburgh
lead OTHER
Principal Investigators
-
David Wilson, MD · University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2018-01-01
- Completion
- 2018-06-01
Countries
- United States
Study Locations
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