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

18 Years
75 Years
Open (Enrolling)
Melanoma, Skin

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Biomarker analysis

Outcome Description:

Skin biomarker and DNA/RNA changes in moles (precursors to melanoma) before and after vitamin D intervention

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jean Yuh Tang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

January 2014

Related Keywords:

  • Melanoma, Skin
  • quality of life
  • Melanoma



Stanford University Cancer InstituteStanford, California  94305