- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00910260
Impact on UVB Narrow Band and UVA1 Therapy on Serum 25-hydroxyvitamin D Levels
Study Overview
Detailed Description
This is an open observational study in dermatological patients undergoing phototherapy.
In patients with a skin disease and the routinely given indication for a phototherapy with UVB narrow-band (UVB nb, 311nm) or UVA1 (340-400 nm), the serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels will be measured before, during and after completion of the 12-week therapy (30 patients per group). Patients will be recruited in the department of dermatology of the University Hospital Zürich in the outpatient clinic. Following oral and written consent, serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels will be measured before the therapy, one week after start as well as after completion of the UVB nb/UVA1 therapy.
In parallel to the study the patients will be asked to fill in a questionnaire evaluating the daily vitamin D consume (milk and milk products, fish, food enhanced in vitamin D, multivitamin supplements), sun exposure per week during previous weeks, degree of tanning, the use of sunscreen, the DLQI and Skindex-29.
A physical examination including clinical score where available will be performed at every "checkpoint". During the first physical examination the Fitzpatrick-skin type of patient will be recorded.
The following participant characteristics will be recorded: age, weight, body mass index (BMI), phototype, skin disease, comorbidities, usual medication, and period of the year where UVB nb/UVA1 therapy is performed (summer vs. winter), cumulative UVB nb/UVA1 doses.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8091
- Dermatology Department, University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Dermatological indication for a phototherapy with UVB nb or UVA1
- Oral and written informed patient consent
Exclusion criteria:
- Interruption of the light therapy for more than 14 days
- Withdrawal of consent to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determination of baseline serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels before therapy
Time Frame: 6 Months
|
6 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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