Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.NCT01261039
Production of Vitamin D Metabolites by UV-radiation From Solar Bed
A study testing UV radiation in people with Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed., run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Background: Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.
- What is being tested?
- UV radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Feb 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Abnormal ALT or Creatinine Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements.
Read more
Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system-including autoimmune diseases-and the cardiovascular system.
Purpose:
The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation.
Study Course:
Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.
Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours.
Day 1,2,3 and 7 after solar bed exposure:
Blood samples are drawn and adverse events are registered.
- Being tested
- UV radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV radiationRadiation
Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes (depending on Fitzpatrick skin type test) on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.
| Study group | Role | What they receive |
|---|---|---|
| Solar bed UV-radiation | Active comparator | Solar bed UV-radiation Receives: Radiation: UV radiation |
| Solar bed with UV filter | Sham comparator | Solar bed with UV filter Receives: Radiation: UV radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D 25-OHD
Measured: 8 days
Secondary outcomes (1)
Changes in other calcium metabolic factors
Vitamin D3, Mg++, PTH, PO4--, Ca++
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Lind Schierbeck, Hvidovre University Hospital
- Investigators
- Jens-Erik B Jensen, MD, PhD, Study chair, Hvidovre University HospitalLouise L Schierbeck, MD, Study chair, Dept. of EndocrinologyUlrich Bang, MD, Study chair, Hvidovre University HospitalJakob H Langdahl, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261039
- Sponsor's protocol ID
- h-3-2009-145
- Status last verified
- Mar 2012
- First submitted
- 15 Dec 2010
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Langdahl JH, Schierbeck LL, Bang UC, Jensen JE. Changes in serum 25-hydroxyvitamin D and cholecalciferol after one whole-body exposure in a commercial tanning bed: a randomized study. Endocrine. 2012 Oct;42(2):430-5. doi: 10.1007/s12020-012-9641-z. Epub 2012 Mar 6.
PubMed 22391940
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of Vitamin D Metabolites by UV-radiation From Solar Bed
- ClinicalTrials.gov ID
- NCT01261039
- Acronym / sponsor ID
- h-3-2009-145
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Dec 2010 (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.
Background:
Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements.
Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system-including autoimmune diseases-and the cardiovascular system.
Purpose:
The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation.
Study Course:
Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.
Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours.
Day 1,2,3 and 7 after solar bed exposure:
Blood samples are drawn and adverse events are registered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solar bed UV-radiation | Active comparator | Radiation: UV radiationSolar bed UV-radiation |
| Solar bed with UV filter | Sham comparator | Radiation: UV radiationSolar bed with UV filter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- Abnormal ALT or Creatinine Pregnancy
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 |
|---|---|---|
| UV radiationSubjects in both groups will be exposed to light in a solar bed for approximately 10 minutes (depending on Fitzpatrick skin type test) on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays. | Radiation | Solar bed UV-radiation, Solar bed with UV filter |
Primary outcome
Vitamin D 25-OHD
Time frame: 8 days
1 secondary outcome
Changes in other calcium metabolic factors
Time frame: 8 days
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 16 Mar 2012.
- Derived from this study: PubMed 22391940Langdahl JH, Schierbeck LL, Bang UC, Jensen JE. Changes in serum 25-hydroxyvitamin D and cholecalciferol after one whole-body exposure in a commercial tanning bed: a randomized study. Endocrine. 2012 Oct;42(2):430-5. doi: 10.1007/s12020-012-9641-z. Epub 2012 Mar 6.
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.
Jens-Erik B Jensen, MD, PhD study chair
Hvidovre University Hospital
Louise L Schierbeck, MD study chair
Dept. of Endocrinology
Ulrich Bang, MD study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UV radiation in people with Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed., run by Hvidovre University Hospital at 1 site in Denmark.
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 16 Mar 2012. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Vitamin D 25-OHD (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01261039, which also lists 1 linked publication.
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 16 Mar 2012.