NCT05387876

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Baylor University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D intervention	Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks
DIETARY_SUPPLEMENT	Placebo intervention	Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-12-03
• Completion: 2023-02-28
• First posted: 2022-05-24
• Last updated: 2022-05-24

Locations

1 site across 1 country: United States