This pilot phase I trial studies vitamin D levels in the skin of healthy subjects after oral supplementation. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of cholecalciferol, a vitamin D, may keep skin cancer from forming.
PRIMARY OBJECTIVES: I. To determine if high-dose oral cholecalciferol supplementation increases vitamin D receptor (VDR) expression in keratinocytes from photoprotected areas in healthy subjects with documented insufficient serum levels of 25-hydroxyvitamin D (defined as =\< 30.0 ng/mL). SECONDARY OBJECTIVES: I. To assess the modulation in CYP24 expression in keratinocytes (from photoprotected and photodamaged skin samples). II. To assess the modulation in VDR expression in keratinocytes (from photodamaged skin samples). III. To assess the mechanistic information concerning the action of cholecalciferol supplementation in the state of keratinocytic differentiation by assessing caspase 14, loricrin, and assessment of stratum corneum thickness. IV. To assess the safety and tolerability of high-dose cholecalciferol supplementation in this patient cohort, including the evaluation of calcium, phosphate, and parathyroid hormone (PTH). V. To assess the 25-hydroxyvitamin D levels after intervention supplementation. TERTIARY OBJECTIVES: I. To assess the corresponding VDR and CYP24 expression in benign melanocytic nevi. (Exploratory) OUTLINE: Participants receive cholecalciferol orally (PO) twice weekly for up to 8-9 weeks. After completion of study treatment, participants are followed up for 10-14 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25
Given PO
University of Arizona Health Sciences Center
Tucson, Arizona, United States
Changes in VDR expression from baseline to post-intervention
Time frame: From baseline to post-intervention
Modulation in CYP24 expression in keratinocytes in photoprotected and photodamaged areas
Time frame: Up to 9 weeks
Modulation of VDR in keratinocytes in photodamaged skin
Time frame: Up to 9 weeks
Changes in a panel of biomarkers of skin differentiation including caspase 14, loricrin, and stratum corneum thickness in keratinocytes in photo-protected and damaged skin
Time frame: From baseline to 9 weeks
Changes in 25-hydroxyvitamin D serum levels
Time frame: From baseline to 9 weeks
Changes in calcium, phosphate, and PTH
Time frame: From baseline to 9 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.