Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

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. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institutes of Health (NIH)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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