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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Placebo intervention; Dietary supplement: Vitamin D intervention

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Waco, Texas, United States, 76798
      • Baylor University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Dietary supplement: Placebo intervention; Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks
Experimental: 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	Dietary supplement: Vitamin D intervention; Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome alterations	Change in the microbiome structure and function	12 weeks

Collaborators and Investigators

• Sponsor: Baylor University
• Investigators: Principal Investigator: Kristen L Greathouse, PhD, Baylor University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): December 3, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: BaylorU-VDMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available at the time of publication in peer-reviewed journal for 10 years.
• IPD Sharing Access Criteria: Signed MTA agreement between study sponsor and requesting entity.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No