Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline
研究概览
简要总结
Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27.
The use of a sunbed will be compared to a control group not using a sunbed in the observation period.
- Trial with medical device
详细描述
We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probands intending to use a commercial sunbed :
- •Age 18 years or older
- •Regular use of commercial sunbeds
- •Oral and written informed consent
排除标准
- •Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27
- •Sunbed use within the last three months
- •Use of vitamin D supplements or multivitamin supplements
- •Any medical condition which renders them unfit for sunbed use in the judgment of the investigator
- •Inability to provide oral and written consent to participate
研究组 & 干预措施
Sunbed
sunbed exposure
干预措施: sunbed exposure (Device)
Observation
only observation of subjects recruited after randomization
结局指标
主要结局
Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline
时间窗: six months
次要结局
未报告次要终点