Vitamin D Levels in the Skin of Healthy Subjects After Oral Supplementation
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|ClinicalTrials.gov Identifier: NCT01447355|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : October 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy, no Evidence of Disease Skin Cancer||Drug: cholecalciferol||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on the Bioactivity of Vitamin D in the Skin After Oral Supplementation|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||June 2013|
Experimental: Prevention (cholecalciferol)
Participants receive cholecalciferol PO twice weekly for up to 8-9 weeks.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|