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临床试验/NCT03609970
NCT03609970已完成不适用

Vitamin D and Immunity: Photosynthesis Versus Supplementation

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 36 人开始时间: 2015年11月19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
36
主要终点
Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated)

研究概览

简要总结

The optimal way to restore serum 25-hydroxyvitamin D sufficiency is currently debatable. UV irradiation through sunshine exposure promotes endogenous vitamin D synthesis, although this can also be associated with a risk of UVR-induced skin cancer. Dietary supplements represent an alternative, which are increasingly being used in clinical trials to correct deficiency. However, it is unclear whether sunshine exposure and vitamin D supplementation induce comparable changes in immune function, or whether additional UVR-induced molecules may be responsible for proposed health benefits. Several studies report an inverse correlation between exposure to UVR and immune-mediated diseases, further supporting the theory that UVR may also be protective through non vitamin-D mediated pathways. So far it has been difficult to distinguish between immune-regulation by vitamin D and other mediators induced by UVR as the downstream effects are similar. A direct comparison of the biological effects of vitamin D obtained by UVR versus supplementation has never been made. This study aims to elucidate the differences in vitamin D generated by UVR exposure versus supplementation by comparing immunological endpoints

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-40
  • Fitzpatrick skin type I/II
  • Serum 25(OH)D3 <50nmol/L

排除标准

  • Serum 25(OH)D3 >50nmol/L
  • Pregnant or nursing women
  • Women of child bearing age not using adequate contraception
  • Are taking photosensitizing medication (i.e. causes you to be more sensitive to sunlight)
  • Have had a history of skin disorders, sensitive skin, sensitivity to sunlight or skin cancer
  • Have previously had an organ transplant
  • Have partaken in a clinical study within the last 14 days
  • Have had recent exposure to sunbeds (last 4 months) or holiday sun (including skiing)
  • Are currently or have taken vitamin D supplements in the last 4 months Are asthmatic or suffer from any allergies

结局指标

主要结局

Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated)

时间窗: 3 years

Measure 25(OH)D3nmol/L via LC-MS/MS

次要结局

  • Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells(3 years)
  • Impact upon the frequency and phenotype of peripheral blood dendritic cells(3 years)
  • Changes to peripheral blood cell frequency(3 years)

研究者

申办方类型
Other
责任方
Sponsor

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