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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00910260
Other study ID # 0000
Secondary ID
Status Completed
Phase Phase 4
First received April 17, 2009
Last updated May 18, 2014
Start date March 2009
Est. completion date February 2011

Study information

Verified date May 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

We plan to investigate the serum elevation of 25(OH)D under UVB nb and UVA1 therapy, in order to determine the effect of these nowadays frequently used wavelengths for phototherapy on vitamin D plasma levels. We hope for a better understanding of steady-state and treatment-induced levels of vitamin D changes to better recognize the impact of phototherapy on vitamin D synthesis in the skin, the dimension of vitamin D production to be expected in the course of standard phototherapy and a potential gap in vitamin D production compared to physiological needs which then should be supplemented orally.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Dermatological indication for a phototherapy with UVB nb or UVA1

2. Oral and written informed patient consent

Exclusion criteria:

1. Interruption of the light therapy for more than 14 days

2. Withdrawal of consent to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Blood analysis
Serum 25-hydroxyvitamin D, calcium, parathormone, phosphate, C-reactive protein and albumin levels will be measured at every visit: day 0, day 7 and day 84.

Locations

Country Name City State
Switzerland Dermatology Department, University Hospital Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of baseline serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels before therapy 6 Months No
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