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.
- Age 18 - 75
- 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 -
- 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)
|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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