Association of Vitamin D Supplementation and Normal Dietary Intake of Vitamin D With Changes in the Gut Microbiome and Markers of Colorectal Cancer Risk
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Placebo intervention
A gummie candy the same consistency and nutrient value as the vitamin D gummie without any vitamin D will be taken as four gummies at the largest meal for 12 weeks once per day
干预措施: Placebo intervention (Dietary Supplement)
Vitamin D intervention
A vitamin D gummie the same consistency and nutrient value as the placebo gummie will be taken as four gummies at the largest meal for 12 weeks once per day providing 4000 IUs per day or 1000 IUs per gummie
干预措施: Vitamin D intervention (Dietary Supplement)
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