- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473317
Sunlight Exposures Effect on Serum Vitamin D Levels
March 30, 2008 updated by: Creighton University
When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is, moved into the bloodstream.
When the skin is exposed to sunlight during summer months, Vitamin D is made there and then modified into more active forms by the liver and kidneys.
These more active forms of Vitamin D improve calcium absorption.
Many adults living in the U.S. have little or no sun exposure and are low in Vitamin D. We know that specific wavelengths of sunlight called Ultraviolet-B cause Vitamin D to be made in the skin.
Study Overview
Detailed Description
At the beginning of the study we will measure your height, weight, skin color, and draw blood to measure your blood levels of Vitamin D and 25-hydroxyvitamin D. Each subject will wear a swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15 minutes lying on stomach).We will draw blood for Vitamin D and 25-hydroxyvitamin D on days 1,2,3,5, and 7 after sunlight exposure.
There will be six blood draws for a total of 102 cc of blood drawn (about 3 ½ teaspoons drawn each time).
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy males or females ages19-50 with "light" skin (self-assessed as Fitzpatrick skin type I-III) with minimal sun exposure and exogenous sources of vitamin D.
Exclusion Criteria:
- less than 16 oz milk per day, less than 10 hours of sun per week, no Vitamin D supplements, no anticonvulsants, no barbiturates, no steroids, no meds that increase photosensitivity, no granulomatous disease, no liver or kidney disease, no history of skin cancer, and BMI less than 30.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
All subjects in this study will be in the active arm
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Each subject will wear a swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15 minutes lying on stomach).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The goal of this study is to correlate vitamin D response and 25(OH)D response to sun exposure with most of the body (90 %) exposed to 0.25 hour of July sunlight at 41.2º N latitude and at approximately 1-2 pm in the afternoon.
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura A Armas, MD, Creighton University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
May 11, 2007
First Submitted That Met QC Criteria
May 11, 2007
First Posted (Estimate)
May 15, 2007
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 30, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Creighton3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.