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Completed

NCT Number: NCT03246308

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, Austria

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phototherapy

Radiation

Taking blood sample.

Primary outcomes

  1. Folate level

    Time frame: 3 years

    The change of the folate levels will be measured at baseline and at the end of phototherapy.

  2. vitamin D level

    Time frame: 3 years

    The change of vitamin D levels will be measured at baseline and at the end of phototherapy.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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