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

Sponsor
Baylor University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05387876
Collaborator
(none)
43
1
2
12.5
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D intervention
  • Dietary Supplement: Placebo intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind placebo controlled randomized intervention of vitamin supplementationDouble blind placebo controlled randomized intervention of vitamin supplementation
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants, investigators and outcomes assessors are masked to intervention group assignments using a researcher outside the study that maintains the study codes and IDs
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Dec 3, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Microbiome alterations [12 weeks]

    Change in the microbiome structure and function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baylor University Waco Texas United States 76798

Sponsors and Collaborators

  • Baylor University

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Baylor University
ClinicalTrials.gov Identifier:
NCT05387876
Other Study ID Numbers:
  • BaylorU-VDMT
First Posted:
May 24, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022