Vitamin D StatusNCT01101243
Maintenance of Vitamin D Level by UVB Radiation
A study testing Broadband UVB in people with Vitamin D Status, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- What is being tested?
- Broadband UVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Apr 2010
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years
- Healthy
Who cannot join
- Sun bed use
- Holiday or business travel south of 45 degrees latitude during trial
- Illness
- Drug addiction
- Pregnancy
- Lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?
The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.
Read the detailed description
The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.
- Conditions
- Vitamin D Status
- Being tested
- Broadband UVB, Control group
- Keywords
- Vitamin D, UVB, Frequency, Body surface area, Dose-Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broadband UVBRadiation
UVB dose: 1 SED every week
Broadband UVBRadiation
UVB dose: 4 SED every second week
Broadband UVBRadiation
UVB dose: 1 SED every second week
Broadband UVBRadiation
UVB dose: 1 SED every month
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Body surface area: 88 % Receives: Radiation: Broadband UVB |
| Group 2 | Active comparator | Body surface area: 22 % Receives: Radiation: Broadband UVB |
| Group 3 | Active comparator | Body surface area: 88 % Receives: Radiation: Broadband UVB |
| Group 4 | Active comparator | Body surface area: 88 % Receives: Radiation: Broadband UVB |
| Group 5 | No intervention | Body surface area: 0 % Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D (nmol/l)
Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level.
Measured: Monthly during 4 months
Secondary outcomes (1)
Parathyroideahormone (pmol/l)
To investigate whether parathyroideahormone is influenced by the UVB radiations.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D StatusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Investigators
- Hans Christian Wulf, Professor, Study chair, Bispebjerg Hospital, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101243
- Sponsor's protocol ID
- H-C-2008-072
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?
- ClinicalTrials.gov ID
- NCT01101243
- Acronym / sponsor ID
- H-C-2008-072
- Conditions
- Vitamin D Status
- Keywords
- Vitamin D, UVB, Frequency, Body surface area, Dose-Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Apr 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.
The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.
Detailed description
The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Radiation: Broadband UVBBody surface area: 88 % |
| Group 2 | Active comparator | Radiation: Broadband UVBBody surface area: 22 % |
| Group 3 | Active comparator | Radiation: Broadband UVBBody surface area: 88 % |
| Group 4 | Active comparator | Radiation: Broadband UVBBody surface area: 88 % |
| Group 5 | No intervention | Other: Control groupBody surface area: 0 % |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years
- Healthy
Key exclusion criteria (6 listed)
- Sun bed use
- Holiday or business travel south of 45 degrees latitude during trial
- Illness
- Drug addiction
- 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 |
|---|---|---|
| Broadband UVBUVB dose: 1 SED every week | Radiation | Group 1 |
| Broadband UVBUVB dose: 4 SED every second week | Radiation | Group 2 |
| Broadband UVBUVB dose: 1 SED every second week | Radiation | Group 3 |
| Broadband UVBUVB dose: 1 SED every month | Radiation | Group 4 |
| Control groupNo intervention | Other | Group 5 |
Primary outcome
Vitamin D (nmol/l)
Time frame: Monthly during 4 months
Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level.
1 secondary outcome
Parathyroideahormone (pmol/l)
Time frame: 4 months
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 9 Apr 2010.
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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 Christian Wulf, Professor study chair
Bispebjerg Hospital, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broadband UVB in people with Vitamin D Status, 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 2 inclusion and 6 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 9 Apr 2010. 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?
Vitamin D (nmol/l) (time frame: Monthly during 4 months). 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 9 Apr 2010.