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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled randomized intervention of vitamin supplementation

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants, investigators and outcomes assessors are masked to intervention group assignments using a researcher outside the study that maintains the study codes and IDs

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Placebo intervention

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Vitamin D intervention

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin D intervention

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

Intervention Type DIETARY_SUPPLEMENT

Placebo intervention

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes