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临床试验/NCT03246308
NCT03246308已完成不适用

Investigation of Vitamin Levels During Phototherapy

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Folate level

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Folate level

时间窗: 3 years

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

vitamin D level

时间窗: 3 years

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedikt Weber

MD PhD

Medical University of Vienna

研究点 (1)

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