Melanoma Clinical Trial
Official title:
INST 0814: The Response of Serum 25-Hydroxyvitamin D to Incidental Ultraviolet Light Exposure
1.1 To detect reproducible variations of serum 25-hydroxyvitamin D levels throughout the
course of one year in relationship to objectively measured levels of ultraviolet exposure.
1.2 To determine specific times within the year that would yield the most significant data
that could be focused on in future, larger studies examining whether there are protective
effects of serum vitamin D on the development of cutaneous melanoma
We will conduct a pilot study to investigate the ability to generate a dose-response curve
of serum 25-hydroxyvitamin D to incidental ultraviolet light exposure measured objectively
with a computerized personal ultraviolet light radiation dosimeter among 10 healthy
volunteers in New Mexico where the population is highly exposed to solar UV radiation.
During the follow-up period we will collect solar exposure data through a self-reported sun
exposure diary, in tandem with objective UV dosimeter data, and will collect blood samples
for serum measurements. We will carry out clinical measurements of serum vitamin D,
parathyroid hormone, and calcium and phosphorus ions. We will analyze the correlation
between the vitamin D and the recorded UV exposure in order to evaluate physiological
changes due to solar exposure. This pilot study is important for melanoma prevention as
there is currently confusion among the public as to how much sun is needed for vitamin D
production and when too much sun exposure will increase risk for developing melanoma.
Expected benefits of this study to the participants include obtaining an objective measure
of daily ultraviolet exposure and vitamin D status and the possible need for
supplementation. Expected benefits to society include determining a dose-response of vitamin
D to ultraviolet light that will enhance our understanding of the balance between necessary
and harmful ultraviolet exposure. The results generated in this pilot study could provide a
scientific basis for designing a larger study to develop effective primary prevention
against cutaneous malignant melanoma.
This pilot study will investigate the ability to generate a dose-response curve of serum
25-hydroxyvitamin D to incidental ultraviolet light exposure measured objectively with a
computerized personal UVR dosimeter. The knowledge obtained will provide important pilot
data a larger NIH grant to estimate the risk-benefit of solar exposure and serum vitamin D
in the development and prevention of cutaneous melanoma.
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Observational Model: Ecologic or Community, Time Perspective: Prospective
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