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

NCT00832533 | Completed DMC

• 1 other identifier: INST 0814
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma

Keywords

Vitamin D; Serum 25-Hydroxyvitamin D; UV exposure; Ultraviolet Light Exposure; Skin Melanoma Advanced

Outcome Measures

Primary Outcomes (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 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Light-skinned volunteers (Caucasians including Hispanics with slightly darker complexion)
• years of age (5 men and 5 women)
• Resident in the State of New Mexico
• Indoor workers with no significant history of prolonged, excessive sun exposure
• Willing to have a monthly blood draw
• Willing to fill out the sun diary every day on different indoor/outdoor activities.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

Universtiy of New Mexico - Cancer Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and Buccal Smear

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Claire Verschraegen, M.D.

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: January 1, 2010
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)