Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers
|ClinicalTrials.gov Identifier: NCT01477463|
Recruitment Status : Completed
First Posted : November 22, 2011
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Melanoma, Skin||Drug: Vitamin D3 Drug: placebo and vitamin D||Not Applicable|
Vitamin D is an important hormone that has multiple genetic effects in different tissue types that are mediated by signaling through the vitamin D receptor.
Recent studies have shown that vitamin D signaling results in decreased innate immunity and increased adaptive immunity.
Multiple epidemiologic studies have suggested that vitamin D may play a role in decreasing the risk of developing multiple types of cancer, including skin cancer.
In the context of the relative success of novel immune-related therapies including PD1 inhibitors, which improves immuno-surveillance, and ipilimumab, which suppresses T cell response, there is increased promise for treatment strategies that activate innate immunity. This led us to ask the question of whether vitamin D could increase immune surveillance for melanoma via increased activity of the adaptive immune system.
Prior studies performed by our group and others have suggested that vitamin D may play a role in decreasing melanoma risk. An epidemiologic study from the Women's Health Initiative showed that women with a prior history of NMSC who received calcium and vitamin D supplementation had a lower risk of subsequently developing melanoma. At the same time, women with a lower serum vitamin D level had a higher risk of developing melanoma. Furthermore, a recent clinical study showed that vitamin D supplementation increases serum vitamin D levels and ultimately results in increased vitamin D receptor signaling in benign nevi.
Taken together, this findings led us to ask whether oral vitamin D supplementation could impact immune signaling in benign nevi and potentially underpin a theoretical chemo-preventive role for vitamin D in melanoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Arm A: Vitamin D
4,000 IU oral vitamin D3
Drug: Vitamin D3
4,000 IU oral vitamin D3
Other Name: 25-hydroxy D3
Experimental: Arm B: Placebo + Vitamin D
Placebo + 4000 IU oral Vitamin D3
Drug: placebo and vitamin D
Other Name: inactive tablet and 25-hydroxy D3
- Number of Genes That Showed Changes in Expression After Vitamin D Treatment [ Time Frame: 2 years ]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.
- Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment [ Time Frame: 2 years ]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.
- Vitamin D Toxicity [ Time Frame: 2 years ]serum 25(OH)D for
- Incidence of Hypercalcemia for Vitamin D Toxicity [ Time Frame: 2 years ]Calcium levels
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477463
|United States, California|
|Stanford University Cancer Institute|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Jean Y Tang, MD, PhD||Stanford University|