Vitamin D DeficiencyNCT00473317
Sunlight Exposures Effect on Serum Vitamin D Levels
A study testing Sun Exposure in people with Vitamin D Deficiency, run by Creighton University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Sun Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2007
- Phase
- Interventional
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Vitamin D Deficiency
- Being tested
- Sun Exposure
- Keywords
- sunlight, UVB, Vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sun ExposureBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects in this study will be in the active arm Receives: Behavioral: Sun Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Investigators
- Laura A Armas, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473317
- Sponsor's protocol ID
- Creighton3
- Status last verified
- Mar 2008
- First submitted
- 11 May 2007
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunlight Exposures Effect on Serum Vitamin D Levels
- ClinicalTrials.gov ID
- NCT00473317
- Acronym / sponsor ID
- Creighton3
- Conditions
- Vitamin D Deficiency
- Keywords
- sunlight, UVB, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 15 May 2007 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Sun ExposureAll subjects in this study will be in the active arm |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sun ExposureEach 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). | Behavioural | 1 |
Primary outcome
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
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 1 Apr 2008.
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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.
Laura A Armas, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sun Exposure in people with Vitamin D Deficiency, run by Creighton University 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 1 inclusion and 1 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 1 Apr 2008. 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?
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). 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 1 Apr 2008.