The Pittsburgh Vitamin D Study: Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer

Stopped early · Not applicable · Has a placebo group

Conditions studied: Deficiency of Vitamin D3, COPD

In brief

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.

Key facts

Study ID

NCT02532062

Run by

University of Pittsburgh

People needed

10

Starts

2016-01-01

Expected to finish

2018-06-01

Last updated by the study team

2018-06-26

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 50 years old.
• Current or ex-smoker with at least 10 pack-year history
• COPD, GOLD II or greater (defined as FEV1/FVC <70% and FEV1 % predicted <80%)
• 25(OH)D3 level ≤25 ng/mL
• Willingness to comply with study guidelines.
• Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
• 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.

You may not qualify if…

• 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 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 participation in another cancer chemoprevention study
• 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.
• Being pregnant

Where it is running

• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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