MelanomaNCT00832533
The Response of Serum 25-Hydroxyvitamin D to Incidental Ultraviolet Light Exposure
An observational study of Melanoma, run by New Mexico Cancer Research Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Light-skinned volunteers (Caucasians including Hispanics with slightly darker complexion)
- 18 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Universtiy of New Mexico - Cancer Center
Albuquerque, New Mexico, 87131-0001
About this study
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
Read the 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.
- Conditions
- Melanoma
- Keywords
- Vitamin D, Serum 25-Hydroxyvitamin D, UV exposure, Ultraviolet Light Exposure, Skin Melanoma Advanced
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Verschraegen, M.D., Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832533
- Sponsor's protocol ID
- INST 0814
- Status last verified
- Sep 2015
- First submitted
- 29 Jan 2009
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INST 0814: The Response of Serum 25-Hydroxyvitamin D to Incidental Ultraviolet Light Exposure
- ClinicalTrials.gov ID
- NCT00832533
- Acronym / sponsor ID
- INST 0814
- Conditions
- Melanoma
- Keywords
- Vitamin D, Serum 25-Hydroxyvitamin D, UV exposure, Ultraviolet Light Exposure, Skin Melanoma Advanced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Light-skinned volunteers (Caucasians including Hispanics with slightly darker complexion)
- 18 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Verschraegen, M.D. principal investigator
University of New Mexico Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by New Mexico Cancer Research Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.