Vitamin D DeficiencyNCT02275650
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
A study testing nbUVB in people with Vitamin D Deficiency, run by Joint Authority for Päijät-Häme Social and Health Care at 2 sites in Finland.
Trial summary
The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- nbUVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesFinland
- Study dates
- Sep 2013to May 2014
- 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
- age over 18
- Fitzpacker's skin type II-IV
Who cannot join
- age under 18
- diseases that inhibit vitamin D metabolism or absorption
- Fitzpacker's skin type I
- history of skin cancer
- vitamin D substitution 1 month before baseline or during study
- sun holidays 1 month before baseline or during study
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Päijät-Häme Central Hospital
Lahdenkylä, Pirkanmaa, 15850
Tampere University Hospital
Tampere, Pirkanmaa, 33521
About this study
The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.
Read the detailed description
The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.
- Conditions
- Vitamin D Deficiency
- Being tested
- nbUVB
- Keywords
- calcidiol, 25(oh)d, nbUVB, cyp27A1, cyp27B1, vitamin D
- Medical subject headings
- Vitamin D Deficiency, Xanthomatosis, Cerebrotendinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nbUVBRadiation
2 SED nbUVB exposure will be given every other week
| Study group | Role | What they receive |
|---|---|---|
| nbUVB | Experimental | 2 SED dose of nbUVB will be given every other week for this intervention group. Receives: Radiation: nbUVB |
| control | No intervention | No nbUVB illumination will be given for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D level
Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.
Measured: up to 30 weeks
Secondary outcomes (1)
CYP27A1 and CYP27B1 enzyme expression levels
CYP27A1 and CYP27B1 enzyme expression levels will be analysed from 6mm punch biopsies at the onset and at week 14.
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Sponsor
- Investigators
- Toni T Karppinen, MD, Principal investigator, Päijät Häme Central HospitalErna Snellman, professor, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275650
- Sponsor's protocol ID
- maintenance_uv
- Status last verified
- Oct 2014
- First submitted
- 19 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
- ClinicalTrials.gov ID
- NCT02275650
- Acronym / sponsor ID
- maintenance_uv
- Conditions
- Vitamin D Deficiency
- Keywords
- calcidiol, 25(oh)d, nbUVB, cyp27A1, cyp27B1, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Oct 2014 (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 investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.
Detailed description
The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nbUVB | Experimental | Radiation: nbUVB2 SED dose of nbUVB will be given every other week for this intervention group. |
| control | No intervention | –No nbUVB illumination will be given for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18
- Fitzpacker's skin type II-IV
Key exclusion criteria (6 listed)
- age under 18
- diseases that inhibit vitamin D metabolism or absorption
- Fitzpacker's skin type I
- history of skin cancer
- vitamin D substitution 1 month before baseline or during study
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 |
|---|---|---|
| nbUVB2 SED nbUVB exposure will be given every other week | Radiation | nbUVB |
Primary outcome
25(OH)D level
Time frame: up to 30 weeks
Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.
1 secondary outcome
CYP27A1 and CYP27B1 enzyme expression levels
Time frame: up to 14 weeks
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 27 Oct 2014.
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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.
Toni T Karppinen, MD principal investigator
Päijät Häme Central Hospital
Erna Snellman, professor study director
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nbUVB in people with Vitamin D Deficiency, run by Joint Authority for Päijät-Häme Social and Health Care at 2 sites in Finland.
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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
25(OH)D level (time frame: up to 30 weeks). 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 27 Oct 2014.