Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
This trial is active, not recruiting.
|Collaborator||National Institutes of Health (NIH)|
|Start date||September 2012|
|End date||June 2014|
|Trial size||20 participants|
|Trial identifier||NCT01477463, 22207, NCI-2012-00043, SKIN0010, SU-10272011-8570|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
4,000 IU oral vitamin D3
Placebo + 4000 IU oral Vitamin D3
time frame: 2 years
time frame: 2 years
Female participants from 18 years up to 75 years old.
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
|Official title||Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers|
|Principal investigator||Jean Yuh Tang, MD, PhD|
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