Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Completed · Not applicable · Has a placebo group
Conditions studied: Melanoma, Skin
In brief
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.
Key facts
- Study ID
- NCT01477463
- Run by
- Stanford University
- People needed
- 24
- Starts
- 2012-09-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2016-12-23
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 -
You may not qualify if…
- 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
Where it is running
- Stanford University Cancer Institute — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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