Investigation of Vitamin Levels During Phototherapy

Phototherapy Complication Clinical Trial

Official title:

Investigation of Vitamin Levels During Phototherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246308
• Other study ID #: 1462/2017
• Status: Completed
• Start date: August 8, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Phototherapy Complication

Intervention

Radiation:
• Phototherapy
Taking blood sample.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Folate level	The change of the folate levels will be measured at baseline and at the end of phototherapy.	3 years
Primary	vitamin D level	The change of vitamin D levels will be measured at baseline and at the end of phototherapy.	3 years