Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02464059
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 18-65 who are current or former smokers
* Serum calcium\<10.5mg/dL
* 25-Hydroxy Vitamin D (OHD)\<20 ng/mL
* Creatinine Clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation
* Women of reproductive potential with negative serum or urine pregnancy test and subjects must refrain from participating in a conception process and subject/partner must use at least 2 reliable forms of contraceptives for the duration of the study
* For participants with COPD, Forced Expiratory Volume in 1 second (FEV1) greater than 50% predicted.
* For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)
Exclusion Criteria:
* Current use of vitamin D supplements
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations
* Pregnancy or currently breast-feeding
* History of nephrolithiasis
* HIV positive serostatus
* Continuous oxygen use \>2 liters/min via nasal cannula
* Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02464059
Study Brief:
Protocol Section:
NCT02464059