Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT05387876
- Run by
- Baylor University
- People needed
- 43
- Starts
- 2022-02-14
- Expected to finish
- 2023-02-28
- Last updated by the study team
- 2022-05-24
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult 18 years or older
You may not qualify if…
- 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
Where it is running
- Baylor University — Waco, Texas, United States
Full record on ClinicalTrials.gov
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