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

This study is currently recruiting participants.
Verified May 2013 by Stanford University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01477463
First received: November 17, 2011
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Melanoma, Skin
 Drug: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Biomarker analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Skin biomarker and DNA/RNA changes in moles (precursors to melanoma) before and after vitamin D intervention


Secondary Outcome Measures:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    serum 25(OH)D and calcium levels for vitamin D toxicity and hypercalcemia


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Vitamin D
4,000 IU oral vitamin D3
 Drug: Vitamin D3
4,000 IU oral vitamin D3
Experimental: Arm B: Placebo + Vitamin D
Placebo + 4000 IU oral Vitamin D3
 Drug: Vitamin D3
4,000 IU oral vitamin D3

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477463

Contacts
Contact: Irene Bailey 650-721-7149 baileyhi@stanford.edu

Locations
United States, California
Stanford University Cancer Institute Recruiting
Palo Alto, California, United States, 94305
Contact: Irene Bailey     650-498-7061     baileyhi@stanford.edu    
Sub-Investigator: Paul A Khavari, MD            
Sub-Investigator: Kavita Sarin, MD, PhD            
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jean Yuh Tang, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01477463     History of Changes
Other Study ID Numbers: SKIN0010, SU-10272011-8570, 22207, NCI-2012-00043
Study First Received: November 17, 2011
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
quality of life

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013