N/A
N=24
Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
Melanoma, Skin
Bottom Line
View on ClinicalTrials.gov: NCT01477463 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Number of Genes That Showed Changes in Expression After Vitamin D Treatment — 270 number of genes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D3 (Drug); placebo and vitamin D (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Genes That Showed Changes in Expression After Vitamin D Treatment |
270 | — |
| PRIMARY Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment |
47 | — |
| SECONDARY Vitamin D Toxicity |
47.11; 29.83 | — |
| SECONDARY Incidence of Hypercalcemia for Vitamin D Toxicity |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 -
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01477463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.