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

Colorectal Cancer Clinical Trial

— VDMT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05387876
• Other study ID #: BaylorU-VDMT
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: February 28, 2023
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Vitamin D intervention
Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks
• Placebo intervention
Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks

Locations

Country	Name	City	State
United States	Baylor University	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome alterations	Change in the microbiome structure and function	12 weeks