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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Placebo intervention; Dietary Supplement: Vitamin D intervention

• Registration Number: NCT05387876
• Lead Sponsor: Baylor University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-14
• Status Verified: 2022-05
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-24
• Primary Completion: 2022-12-03
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo intervention	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
Vitamin D intervention	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

Primary Outcome Measures

Name	Time	Method
Microbiome alterations	12 weeks	Change in the microbiome structure and function

Trial Locations

Locations (1)

Baylor University; 🇺🇸 Waco, Texas, United States