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Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Not Recruiting
Trial ID: NCT01477463
Purpose
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. If vitamin D is found to inhibit a signaling pathway involved in
the development of melanoma such as BRAF, a protein involved in cell proliferation, then oral
vitamin D could be explored further as a chemoprevention for melanoma skin cancer.
Official Title
Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Stanford Investigator(s)
Paul A. Khavari, MD, PhD
Carl J. Herzog Professor of Dermatology in the School of Medicine
Eligibility
Inclusion Criteria:
1. Age 18 - 75
2. Female
3. White race/ethnicity
4. With history of non-melanoma skin cancer
5. Has 12-16 moles upon skin examination
6. Consents to 6-12 moles biopsies over 2-3 clinic visits (2-4 months)
7. Consents to ingesting oral vitamin D3 or placebo daily for 2-4 months
8. Consents to abstaining from other multivitamins during study
9. Consents to research use of their tissue and blood samples
10. Agrees to apply a sunscreen of SPF 45 during study -
Exclusion Criteria:
1. History or current evidence of hyperparathyroidism, hypercalcemia, renal calculi, or
other renal disease.
2. History or current evidence of malabsorptive illnesses, such as IBD, or liver disease
that would impair uptake or metabolism of vitamin D.
3. History or current evidence of hyperthyroidism that would increase metabolism of
vitamin D.
4. History or current evidence of immunosuppression (cancer, autoimmune disease) or
taking immunosuppressive drugs.
5. Currently taking medications that would affect metabolism of vitamin D
(anticonvulsants, corticosteroids, H2-receptor antagonists).
6. Currently taking medications that predispose to hypercalcemia (digoxin, lithium,
thiazide diuretics) or other electrolyte disturbances (aluminum hydroxide)
7. Pregnancy
Intervention(s):
drug: Vitamin D3
drug: Vitamin D3
drug: placebo and vitamin D
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
ccto-office@stanford.edu
650-498-7061