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

NCT01477463 | Completed Results DMC

• 4 other identifiers: SKIN0010SU-10272011-8570IRB-222075K23AR056736
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma, Skin

Keywords

quality of life

Outcome Measures

Primary Outcomes (2)

• Number of Genes That Showed Changes in Expression After Vitamin D Treatment

  Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.

  2 years

• Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment

  We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups.

  2 years

Secondary Outcomes (2)

• Vitamin D Toxicity

  2 years

• Incidence of Hypercalcemia for Vitamin D Toxicity

  2 years

Study Arms (2)

Arm A: Vitamin D

EXPERIMENTAL

4,000 IU oral vitamin D3

Drug: Vitamin D3

Arm B: Placebo + Vitamin D

EXPERIMENTAL

Placebo + 4000 IU oral Vitamin D3

Drug: placebo and vitamin D

Interventions

Vitamin D3 DRUG

4,000 IU oral vitamin D3

Also known as: 25-hydroxy D3

Arm A: Vitamin D

placebo and vitamin D DRUG

Also known as: inactive tablet and 25-hydroxy D3

Arm B: Placebo + Vitamin D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Stanford University Cancer Institute

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cholecalciferol; 25-hydroxyvitamin D3-3-(1,2-epoxypropyl)ether; Vitamin D

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Jean Y Tang MD PhD, assistant professor
• Organization: Stanford University School of Medicine

baileyhi@stanford.edu

650-721-7149

Study Officials

• Jean Y Tang, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 23, 2016
• Results First Posted: December 23, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)