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

Baylor University

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Vitamin D intervention; Dietary Supplement: Placebo intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05387876

BaylorU-VDMT

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

Placebo intervention

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo intervention

Vitamin D intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D intervention