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

Melanoma, Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01477463
• Other study ID #: SKIN0010
• Secondary ID: SU-10272011-8570
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2011
• Last updated: March 13, 2014
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Melanoma, Skin

Intervention

Drug:
• Vitamin D3
4,000 IU oral vitamin D3
• Vitamin D3
4,000 IU oral vitamin D3

Locations

Country	Name	City	State
United States	Stanford University Cancer Institute	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker analysis	Skin biomarker and DNA/RNA changes in moles (precursors to melanoma) before and after vitamin D intervention	2 years	No
Secondary	Safety	serum 25(OH)D and calcium levels for vitamin D toxicity and hypercalcemia	2 years	Yes