Vitamin D Levels in the Skin of Healthy Subjects After Oral Supplementation
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.
Healthy, no Evidence of Disease
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pilot Study on the Bioactivity of Vitamin D in the Skin After Oral Supplementation|
- Changes in VDR expression from baseline to post-intervention [ Time Frame: From baseline to post-intervention ] [ Designated as safety issue: No ]
- Modulation in CYP24 expression in keratinocytes in photoprotected and photodamaged areas [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
- Modulation of VDR in keratinocytes in photodamaged skin [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Changes in 25-hydroxyvitamin D serum levels [ Time Frame: From baseline to 9 weeks ] [ Designated as safety issue: No ]
- Changes in calcium, phosphate, and PTH [ Time Frame: From baseline to 9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Prevention (cholecalciferol)
Participants receive cholecalciferol PO twice weekly for up to 8-9 weeks.
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).
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.
I. To assess the corresponding VDR and CYP24 expression in benign melanocytic nevi. (Exploratory)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447355
|United States, Arizona|
|University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Clara Curiel-Lewandrowski||University of Arizona Health Sciences Center|