Vitamin D StatusNCT01074541
The Vitamin D Dose-Response Relationship
A study testing 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 importance of the UV intensity and the UVB dose on the Vitamin D response after UVB. 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?
- UVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Feb 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.
Denmark1 site
Bispebjerg Hospital, Department of Dermatology
Copenhagen NV, NV, 2400
About this study
Official title: Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial
The purpose of the study is to determine the importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.
Read the detailed description
The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships.
Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.
- Conditions
- Vitamin D Status
- Being tested
- UVB
- Keywords
- Vitamin D, UVB, Dose-Response, UV intensity, Skin cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVBRadiation
Also called UVB radiation
0.375 SED x 4 in a week
UVBRadiation
Also called UVB radiation
0.75 SED x 4 in a week
UVBRadiation
Also called UVB radiation
1.5 SED x 4 in a week
UVBRadiation
Also called UVB radiation
3.0 SED x 4 in a week
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | UV intensity 10 MIN Receives: Radiation: UVB |
| Group 2 | Active comparator | UV intensity 5 MIN Receives: Radiation: UVB |
| Group 3 | Active comparator | UV intensity 1 MIN Receives: Radiation: UVB |
| Group 4 | Active comparator | UV intensity 20 MIN Receives: Radiation: UVB |
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 dose-response relationship between UVB dose, UV intensity and Vitamin D production in the skin after UVB exposure.
Measured: 2 days after exposure
Secondary outcomes (1)
Other parameters
To invesitage whether other parameters like sex, BMI, Diet etc. influences the vitamin D production after UVB exposure.
Measured: 2 days after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionFeb 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
- 55 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, Deparment of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074541
- Sponsor's protocol ID
- 271-08-0461
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2010
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01074541
- Acronym / sponsor ID
- 271-08-0461
- Conditions
- Vitamin D Status
- Keywords
- Vitamin D, UVB, Dose-Response, UV intensity, Skin cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Feb 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 importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.
Detailed description
The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships.
Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Radiation: UVBUV intensity 10 MIN |
| Group 2 | Active comparator | Radiation: UVBUV intensity 5 MIN |
| Group 3 | Active comparator | Radiation: UVBUV intensity 1 MIN |
| Group 4 | Active comparator | Radiation: UVBUV intensity 20 MIN |
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 |
|---|---|---|
| UVBAlso: UVB radiation0.375 SED x 4 in a week | Radiation | Group 1, Group 2 |
| UVBAlso: UVB radiation0.75 SED x 4 in a week | Radiation | Group 1, Group 2 |
| UVBAlso: UVB radiation1.5 SED x 4 in a week | Radiation | Group 1, Group 2, Group 4 |
| UVBAlso: UVB radiation3.0 SED x 4 in a week | Radiation | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Vitamin D (nmol/l)
Time frame: 2 days after exposure
Vitamin D measured in a blood sample to define the dose-response relationship between UVB dose, UV intensity and Vitamin D production in the skin after UVB exposure.
1 secondary outcome
Other parameters
Time frame: 2 days after radiation
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 24 Feb 2010.
Related trials for Vitamin D Status
Recruiting
Impact of Trout Fish, Cow Milk With Egg, Vitamin D Supplementation, and Dietary Education on Vitamin D Status, Undernutrition, and Neurocognitive Outcomes Among School Children in Pakistan: An Open-label Individually Randomized Controlled Trial
Vitamin D 25-Hydroxylase Deficiency, Undernutrition
Enrolling by invitationObservational study
Vitamin D Status and Its Influencing Factors in Zhejiang Province: A Multicenter Cross-Sectional Study
Vitamin D Deficiency
Recruiting
Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
Healthy Adult Participants, Vitamin D Insufficiency
RecruitingObservational study
Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
Locally Advanced Cervical Cancer, Vitamin D Concentration
Not yet recruitingObservational study
Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma
Bronchial Asthma, Vitamin D Deficiency
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, Deparment 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 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 24 Feb 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: 2 days after exposure). 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 24 Feb 2010.