The Pittsburgh Vitamin D Study: Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 26, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- University of Pittsburgh
- Interventions being studied
- Dietary Supplement: Cholecalciferol; Dietary Supplement: multivitamin; Dietary Supplement: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Age ≥ 50 years old. 2. Current or ex-smoker with at least 10 pack-year history 3. COPD, GOLD II or greater (defined as FEV1/FVC \<70% and FEV1 % predicted \<80%) 4. 25(OH)D3 level ≤25 ng/mL 5. Willingness to comply with study guidelines. 6. Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial 7. Participant 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.
1. Personal history of lung cancer or head and neck cancer 2. History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue). 3. History of known thyroid disease 4. History of known sarcoid disease 5. History of known abnormalities in calcium metabolism 6. Hypercalcemia (serum calcium in excess of laboratory ULN) 7. Self-reported consumption of more than 4 alcoholic drinks per day 8. Use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin D metabolism 9. History of known renal dysfunction 10. History of known nephrolithiasis (kidney stones) 11. Current participation in another cancer chemoprevention study 12. Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug. 13. Inability to swallow pills. 14. Vitamin D supplementation \> 2,000 IU/day of vitamin D within 30 days prior to enrollment. 15. Being pregnant
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 26, 2018. Always confirm current availability with the study team.