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Sponsored by: |
University of New Mexico |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00832533 |
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
Condition |
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Melanoma |
Study Type: | Observational |
Study Design: | Ecologic or Community, Prospective |
Official Title: | INST 0814: The Response of Serum 25-Hydroxyvitamin D to Incidental Ultraviolet Light Exposure |
Blood samples and Buccal Smear
Estimated Enrollment: | 10 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
2 participants with Hispanic ethnicity are represented as well. Darker-skinned individuals, such as African Americans, produce considerably less vitamin D. Inclusion of African Americans will be critical. Asians and African Americans do develop melanoma, but at a rate ten times less than Caucasians and it does not appear to be related to sun exposure; thus, to include them at this time would not allow us to focus on the medically-related issue.
Inclusion Criteria:
Further explanation of the inclusion criteria:
This pilot study is intended to evaluate the dose-response associations between measured UV exposure and individual serum 25 (OH)-vitamin D levels. To date, there is little data and a great deal of mis-information about vitamin D. Caucasians have a variety of skin types and melanin production. This pilot study is unfunded and we know that there is extreme heterogeneity among Caucasians in their absorption of UVB and subsequent synthesis of vitamin D. Among our volunteers 2 participants with Hispanic ethnicity are represented as well.
Darker-skinned individuals, such as African Americans, produce considerably less vitamin D, based on the bone health literature. Inclusion of African Americans will be critical in the future as we develop our understanding of the relationship between vitamin D and UV exposure. Our collaborator, Elizabeth Jacobs at the University of Arizona, is currently conducting a pilot study to evaluate UV and serum vitamin D among individuals with darker pigmentation. The motivation for our pilot study has to do with the balance between vitamin D and sun exposure as a risk-benefit assessment for the development of melanoma. Asians and African Americans do develop melanoma, but at a rate ten times less than Caucasians and it does not appear to be related to sun exposure; thus, to include them at this time would not allow us to focus on the medically-related issue.
Exclusion Criteria:
Contact: Leanne Gideon | 505-272-7090 | LGideon@salud.unm.edu |
United States, New Mexico | |
Universtiy of New Mexico - Cancer Center | Recruiting |
Albuquerque, New Mexico, United States, 87131-0001 | |
Contact: Leanne Gideon 505-272-7090 LGideon@salud.unm.edu | |
Principal Investigator: Claire Verschraegen, M.D. |
Principal Investigator: | Claire Verschraegen, M.D. | University of New Mexico |
Responsible Party: | Universit of New Mexico - Cancer Center ( Claire F. Verschraegen, M.D., PI ) |
Study ID Numbers: | INST 0814 |
Study First Received: | January 29, 2009 |
Last Updated: | July 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00832533 History of Changes |
Health Authority: | United States: Institutional Review Board |
Vitamin D Serum 25-Hydroxyvitamin D UV exposure Ultraviolet Light Exposure Skin Melanoma Advanced |
1-hydroxycholecalciferol Bone Density Conservation Agents Trace Elements Hydroxycholecalciferols Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Vitamin D |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Vitamins Neuroepithelioma Micronutrients Nevus Melanoma, Familial |
Neoplasms by Histologic Type Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions Hydroxycholecalciferols Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Vitamins Nevi and Melanomas Micronutrients |