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

NCT05387876 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-05-24

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D intervention

Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks

DIETARY_SUPPLEMENT

Placebo intervention

Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks

Sponsors & Collaborators

  • Baylor University

    lead OTHER

Principal Investigators

  • Kristen L Greathouse, PhD · Baylor University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2022-12-03
Completion
2023-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387876 on ClinicalTrials.gov