HealthyNCT00516867
Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?
A study testing UV radiation in people with Healthy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UV radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Apr 2006
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Females
- Above 50 years
- Younger with serum concentration of 25(OH)D below 50nmol/l
Who cannot join
- No sunbed use last ½ year
- No sun holiday last ½ year
- No intake of vitamin D above 10 microgram/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sunbed Radiation Provoke Cutaneous Vitamin D Synthesis in Humans, a Randomized Controlled Trial
We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent on the UVB dose?
- Conditions
- Healthy
- 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
UV radiation with 99.5% UVA and 0.5%UVB
UV radiationRadiation
UVB 1.4 % and UVA 98.6
| Study group | Role | What they receive |
|---|---|---|
| UVB 0.5% | Active comparator | Not described Receives: Radiation: UV radiation |
| Controls | No intervention | Not described |
| UVB 1.4% | Active comparator | Not described Receives: Radiation: UV radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of 25(OH)D
Measured: 18 Days
Secondary outcomes (1)
Serum concentration of PTH
Measured: 18 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startFeb 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Investigators
- Hans C Wulf, MD, DSc, Study chair, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516867
- Sponsor's protocol ID
- KF 01 290815
- Status last verified
- Aug 2007
- First submitted
- 14 Aug 2007
- Last updated
- 16 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunbed Radiation Provoke Cutaneous Vitamin D Synthesis in Humans, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00516867
- Acronym / sponsor ID
- KF 01 290815
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- Feb 2006
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Aug 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.
We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent on the UVB dose?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UVB 0.5% | Active comparator | Radiation: UV radiation |
| Controls | No intervention | – |
| UVB 1.4% | Active comparator | Radiation: UV radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy
- Females
- Above 50 years
- Younger with serum concentration of 25(OH)D below 50nmol/l
Key exclusion criteria (3 listed)
- No sunbed use last ½ year
- No sun holiday last ½ year
- No intake of vitamin D above 10 microgram/day
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 radiationUV radiation with 99.5% UVA and 0.5%UVB | Radiation | UVB 0.5% |
| UV radiationUVB 1.4 % and UVA 98.6 | Radiation | UVB 1.4% |
Primary outcome
Serum concentration of 25(OH)D
Time frame: 18 Days
1 secondary outcome
Serum concentration of PTH
Time frame: 18 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 Aug 2007.
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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.
Hans C Wulf, MD, DSc study chair
Bispebjerg 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 Healthy, run by Bispebjerg 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 4 inclusion and 3 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 Aug 2007. 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. 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?
Serum concentration of 25(OH)D (time frame: 18 Days). 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 16 Aug 2007.