跳至主要内容
临床试验/NCT05387876
NCT05387876Unknown不适用

Association of Vitamin D Supplementation and Normal Dietary Intake of Vitamin D With Changes in the Gut Microbiome and Markers of Colorectal Cancer Risk

Baylor University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
43
试验地点
2
主要终点
Microbiome alterations

研究概览

简要总结

Although dietary vitamin D supplementation has been used in the clinical setting for decades, the effect of supplementary vitamin D consumption on the structure of the microbiome has not been studied in humans in fine scale or with concomitant adjustment for dietary intake. Understanding the interaction of vitamin D with the microbiome in humans could lead to important advancements in the understanding of how vitamin D together with diet impacts the microbiome composition, and ultimately, risk of EOCRC. This study has the potential to lay the ground work for an adjunctive therapy to manipulate the microbiome to reduce risk of EOCRC. This proposed study is designed to evaluate the effect of vitamin D supplementation on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants, investigators and outcomes assessors are masked to intervention group assignments using a researcher outside the study that maintains the study codes and IDs

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult 18 years or older

排除标准

  • Women who are currently pregnant or breastfeeding
  • Use of antibiotics within the last 2 weeks
  • Use of supplementary vitamin D within the last month
  • Self-reported, pre-existing history of inflammatory bowel disease, heart disease or diabetes
  • Students under 18
  • Tanning/sun exposure > 60 min at a time in last 4 weeks
  • No phenobarbital, carbamazepine, spironolactone chronic therapy; or steroid use within the last 2 weeks
  • Severe allergy to ingredients found in supplements

结局指标

主要结局

Microbiome alterations

时间窗: 12 weeks

Change in the microbiome structure and function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验