Impact on UVB Narrow Band and UVA1 Therapy on Serum 25-hydroxyvitamin D Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00910260
First received: April 17, 2009
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Skin Disease
Procedure: Blood analysis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact on UVB Narrow Band and UVA1 Therapy on Serum 25-hydroxyvitamin D Levels

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Determination of baseline serum 25-hydroxyvitamin D, calcium, parathormone, phosphate and albumin levels before therapy [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 116
Study Start Date: March 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

dermatology clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910260

Locations
Switzerland
Dermatology Department, University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00910260     History of Changes
Other Study ID Numbers: 0000
Study First Received: April 17, 2009
Last Updated: May 18, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
vitamin D level under phototherapy

Additional relevant MeSH terms:
Skin Diseases
Hydroxycholecalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 21, 2014