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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01477463
First received: November 17, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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:


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: December 2014
Estimated Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University Cancer Institute
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
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: March 13, 2014
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 July 22, 2014