The Response of Serum 25-Hydroxyvitamin D to Incidental Ultraviolet Light Exposure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832533
First received: January 29, 2009
Last updated: September 23, 2011
Last verified: March 2010
  Purpose

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
Melanoma

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: INST 0814: The Response of Serum 25-Hydroxyvitamin D to Incidental Ultraviolet Light Exposure

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood samples and Buccal Smear


Estimated Enrollment: 10
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  1. Light-skinned volunteers (Caucasians including Hispanics with slightly darker complexion)
  2. 18 years of age (5 men and 5 women)
  3. Resident in the State of New Mexico
  4. Indoor workers with no significant history of prolonged, excessive sun exposure
  5. Willing to have a monthly blood draw
  6. Willing to fill out the sun diary every day on different indoor/outdoor activities.
  7. During the project time period potential pregnancy of women volunteers would change the risk category of the participants, and that is a reportable event to UNM HSC HRRC and the Clinical Trial Office.

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:

  1. Diet high in oily fish (e.g. eating cod liver or sardines oil conserved products more than 2-3 times/week)
  2. Oral vitamin D supplementation (over 1,000 IU/day amount)
  3. Tanning bed use.
  4. Existing 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: NCT00832533

Locations
United States, New Mexico
Universtiy of New Mexico - Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Claire Verschraegen, M.D. University of New Mexico Cancer Center
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832533     History of Changes
Other Study ID Numbers: INST 0814
Study First Received: January 29, 2009
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Vitamin D
Serum 25-Hydroxyvitamin D
UV exposure
Ultraviolet Light Exposure
Skin Melanoma Advanced

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
Hydroxycholecalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 21, 2014