Vitamin D DeficiencyNCT01512537
Alternative Treatments of Vitamin D Deficiency
A study testing Narrowband UVB and Vitamin D and calcium in people with Vitamin D Deficiency, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Narrowband UVB and Vitamin D and calcium
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2010to Nov 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Vitamin D deficiency (< 25 nmol/l)
- Age 15 or above
Who cannot join
- Travel south of 45 degrees latitude during the trial.
- Ongoing treatment with vitamin D supplementation.
- Intake of light sensitive medicine, such as tetracyclins.
- Skin light eruptions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency
The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.
Read the detailed description
Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation.
- Conditions
- Vitamin D Deficiency
- Being tested
- Narrowband UVB, Vitamin D and calcium
- Keywords
- Vitamin D, UVB, Vitamin D supplementation
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband UVBRadiation
Also called NB-UVB
UVB 3 times a week
Vitamin D and calciumDietary supplement
Also called Vitamin D supplementation
1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium
| Study group | Role | What they receive |
|---|---|---|
| UVB | Active comparator | UVB exposed group Receives: Radiation: Narrowband UVB |
| Oral vitamin D tablet | Active comparator | Vitamin D supplementation Receives: Dietary Supplement: Vitamin D and calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D (nmol/l).
Vitamin D was measured in a bloodsample to determine baseline status.
Measured: Week 0
Vitamin D (nmol/l)
Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.
Measured: Week 3
Vitamin D
Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.
Measured: Week 6
Secondary outcomes (4)
Parathyroid hormone (pmol/l).
To investigate whether parathyrodiea hormone changes during the study.
Measured: Week 0, 3 and 6.
Albumin (g/l).
To investigate whether albumin changes during the study.
Measured: Week 0, 3 and 6.
Calcium (mmol/l)
To investigate whether calcium changes during the study.
Measured: Week 0, 3 and 6.
Hemoglobin A 1c (percentage HbA1c of total hemoglobin).
To investigate whether HbA1c changes during the study.
Measured: Week 0, 3 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionNov 2011
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.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Bogh, Lund University
- Investigators
- Åke Svensson, Assoc. Prof., MD, PhD, Study chair, Department of Dermatology, Lund University, Malmoe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512537
- Sponsor's protocol ID
- 2009/687
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT01512537
- Acronym / sponsor ID
- 2009/687
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, UVB, Vitamin D supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Jan 2012 (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 compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.
Detailed description
Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVB | Active comparator | Radiation: Narrowband UVBUVB exposed group |
| Oral vitamin D tablet | Active comparator | Dietary Supplement: Vitamin D and calciumVitamin D supplementation |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Vitamin D deficiency (< 25 nmol/l)
- Age 15 or above
Key exclusion criteria (4 listed)
- Travel south of 45 degrees latitude during the trial.
- Ongoing treatment with vitamin D supplementation.
- Intake of light sensitive medicine, such as tetracyclins.
- Skin light eruptions
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 |
|---|---|---|
| Narrowband UVBAlso: NB-UVBUVB 3 times a week | Radiation | UVB |
| Vitamin D and calciumAlso: Vitamin D supplementation1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium | Dietary supplement | Oral vitamin D tablet |
Primary outcome
Vitamin D (nmol/l).
Time frame: Week 0
Vitamin D was measured in a bloodsample to determine baseline status.
Vitamin D (nmol/l)
Time frame: Week 3
Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.
Vitamin D
Time frame: Week 6
Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.
4 secondary outcomes
Parathyroid hormone (pmol/l).
Time frame: Week 0, 3 and 6.
Albumin (g/l).
Time frame: Week 0, 3 and 6.
Calcium (mmol/l)
Time frame: Week 0, 3 and 6.
Hemoglobin A 1c (percentage HbA1c of total hemoglobin).
Time frame: Week 0, 3 and 6.
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 19 Jan 2012.
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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.
Åke Svensson, Assoc. Prof., MD, PhD study chair
Department of Dermatology, Lund University, Malmoe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrowband UVB and Vitamin D and calcium in people with Vitamin D Deficiency, run by Lund University at 1 site in Sweden.
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 4 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 19 Jan 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 Sweden. 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: Week 0). The study lists 3 primary outcomes in all. 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 19 Jan 2012.