Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD

• Status: Completed
• Trial end date: 2020-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This proposal will evaluate a potential mechanism of increased risk of lung function impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this pathway. This study will improve the understanding of factors which can lead to chronic lung disease. If effective, this application would also provide the justification to study vitamin D as a therapy to improve lung health.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Johns Hopkins University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.