This trial is active, not recruiting.

Condition melanoma, skin
Treatments vitamin d3
Sponsor Stanford University
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
4,000 IU oral vitamin D3
vitamin d3
4,000 IU oral vitamin D3
Placebo + 4000 IU oral Vitamin D3
vitamin d3
4,000 IU oral vitamin D3

Primary Outcomes

Biomarker analysis
time frame: 2 years

Secondary Outcomes

time frame: 2 years

Eligibility Criteria

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

Additional Information

Official title Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Principal investigator Jean Yuh Tang, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Stanford University.