Investigation of Vitamin Levels During Phototherapy

Research project in which blood samples of patients undergoing UVB phototherapy for the treatment of different cutaneous diseases will be investigated for changes of folate levels and further vitamins over the course of treatment.

Study Overview

• Status: Completed
• Conditions: Phototherapy Complication
• Intervention / Treatment: Radiation: Phototherapy

Detailed Description

UVB phototherapy is used to treat a plethora of different dermatoses with a favorable side effect profile compared to systemic alternatives. One rarely mentioned issue related to phototherapy is the question of whether it holds potential to decrease folate serum levels, which is of particular interest to women of childbearing age, as birth defects, such as neural tube defects (NTD), cardiac defects, and facial clefting have all been noted to be increased in women with folate deficiency. Several studies, involving different patient groups and modes of phototherapy, have investigated the changes of folate levels throughout therapy showing mixed results. While two small open studies from Egypt showed a significant reduction of folate levels after 24 and 18 / 36 exposures (1-2), several other studies failed to show a significant change (3-6). In addition, there are also conflicting data on the influence of UVB phototherapy on vitamin D, vitamin B12 and homocysteine levels. Therefore, the presented prospective trial aims at investigating the changes of these vitamins during a routine course of phototherapy. The study will focus on the following specific aims: Measure the levels of folate as well as the levels of further vitamin parameters (including homocysteine, 25-OH-vitamin D3, 1,25-OH-vitamin D3, holotranscobalamin and methylmalonic acid) before and during phototherapy (at baseline, after 12, 24 and 36 exposures and/or at the end of treatment)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing UVB therapy.

Description

Inclusion Criteria:

• Patients undergoing UVB phototherapy (narrowband UVB or broadband UVB)
• Male and female participants minimum 18 years old
• Written informed consent by the participant after information about the research project

Exclusion Criteria:

• Regular sunbed use
• Underlying disease with abnormal folate metabolism (e.g. thalassemia)
• Age below 18 years
• Patients who will not be able to attend regularly for treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Folate level	The change of the folate levels will be measured at baseline and at the end of phototherapy.	3 years
vitamin D level	The change of vitamin D levels will be measured at baseline and at the end of phototherapy.	3 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1462/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No