Status:
COMPLETED
Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Melanoma, Skin
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the signaling pathways and changes in gene expression in melanocytes of subjects with a history of non-melanoma skin cancer who are exposed to oral vitamin D....
Detailed Description
Background: Vitamin D is an important hormone that has multiple genetic effects in different tissue types that are mediated by signaling through the vitamin D receptor. Recent studies have shown tha...
Eligibility Criteria
Inclusion
- Age 18 - 75
- Female
- White race/ethnicity
- With history of non-melanoma skin cancer
- Has 12-16 moles upon skin examination
- Consents to 6-12 moles biopsies over 2-3 clinic visits (2-4 months)
- Consents to ingesting oral vitamin D3 or placebo daily for 2-4 months
- Consents to abstaining from other multivitamins during study
- Consents to research use of their tissue and blood samples
- Agrees to apply a sunscreen of SPF 45 during study -
Exclusion
- History or current evidence of hyperparathyroidism, hypercalcemia, renal calculi, or other renal disease.
- History or current evidence of malabsorptive illnesses, such as IBD, or liver disease that would impair uptake or metabolism of vitamin D.
- History or current evidence of hyperthyroidism that would increase metabolism of vitamin D.
- History or current evidence of immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
- Currently taking medications that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists).
- Currently taking medications that predispose to hypercalcemia (digoxin, lithium, thiazide diuretics) or other electrolyte disturbances (aluminum hydroxide)
- Pregnancy
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01477463
Start Date
September 1 2012
End Date
May 1 2014
Last Update
December 23 2016
Active Locations (1)
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1
Stanford University Cancer Institute
Palo Alto, California, United States, 94305