Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults (VDMT)

Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults

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

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.

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

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

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

Inclusion Criteria: Adult 18 years or older Exclusion Criteria: 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

Study participant de-identified data will be shared with other researchers who submit a request for data acquisition. An MTA agreement will be constructed for protection of data sharing between the two researchers.