Vitamin D Levels in the Skin of Healthy Subjects After Oral Supplementation

Skin Cancer Clinical Trial

Official title: Pilot Study on the Bioactivity of Vitamin D in the Skin After Oral Supplementation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease
• Skin Cancer

• NCT number: NCT01447355
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Completion date: June 2013