Vitamin D and Immunity: Photosynthesis Versus Supplementation (IMMUNI-D)
2018年7月25日 更新者：Guy's and St Thomas' NHS Foundation Trust
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
研究概览
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age: 18-40
- Fitzpatrick skin type I/II
- Healthy
- Serum 25(OH)D3 <50nmol/L
Exclusion Criteria:
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制
无干预
|
|
|
实验性的：UVR (Solar simulated radiation)
Twice weekly 1.25 SED (sub-erythemal) (4 weeks)
|
1.25 SED Solar simulated radiation twice weekly
|
|
实验性的：Vitamin D3 supplementation
4X 1000IU cholecalciferol tablets daily (28 days)
|
Daily 4X 1000IU cholecalciferol
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vitamin D status of healthy participants treated with oral vitamin D (cholecalciferol) or UVR (SSR) exposures and control (untreated)
大体时间：3 years
|
Measure 25(OH)D3nmol/L via LC-MS/MS
|
3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes to peripheral blood cell frequency
大体时间：3 years
|
Frequency of major peripheral immune cells (e.g.
CD3+ T cells, CD3+ CD4+ T cells, CD3+ CD8+ T cells, CD19+ B cells, Natural Killer Cells, Classical, Non-classical and Intermediate Monocytes) in participants when vitamin D insufficient and sufficient.
Via flow cytometry.
|
3 years
|
|
Impact upon the frequency and phenotype of peripheral blood dendritic cells
大体时间：3 years
|
Frequency of peripheral blood dendritic cells (myeloid and plasmacytoid) in individuals with insufficient vitamin D levels and following vitamin D repletion via supplementation or UVR (SSR) exposures.
Assessment of markers of maturation/tolerogenicity (MFI and frequency expressing) on myeloid and plasmacytoid dendritic cells direct ex vivo and after stimulation in vitro in participants when vitamin D insufficient and sufficient.
|
3 years
|
|
Gene expression in peripheral blood myeloid and plasmacytoid dendritic cells
大体时间：3 years
|
Differentially regulated genes in myeloid and plasmacytoid dendritic cells in participants after vitamin D repletion via supplementation and UVR (SSR) exposure via Microarray.
|
3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Antony Young、King's College London
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月19日
初级完成 (实际的)
2017年4月14日
研究完成 (实际的)
2017年4月14日
研究注册日期
首次提交
2018年6月22日
首先提交符合 QC 标准的
2018年7月25日
首次发布 (实际的)
2018年8月1日
研究记录更新
最后更新发布 (实际的)
2018年8月1日
上次提交的符合 QC 标准的更新
2018年7月25日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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