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

NCT05387876 | Unknown DMC

• 1 other identifier: BaylorU-VDMT
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Microbiome alterations

  Change in the microbiome structure and function

  12 weeks

Study Arms (2)

Placebo intervention

PLACEBO COMPARATOR

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

Vitamin D intervention

EXPERIMENTAL

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

Interventions

Vitamin D intervention DIETARY_SUPPLEMENT

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

Vitamin D intervention

Placebo intervention DIETARY_SUPPLEMENT

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

Placebo intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kristen L Greathouse, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators and outcomes assessors are masked to intervention group assignments using a researcher outside the study that maintains the study codes and IDs
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind placebo controlled randomized intervention of vitamin supplementation

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 24, 2022
• Study Start: February 14, 2022
• Primary Completion: December 3, 2022
• Study Completion: February 28, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available at the time of publication in peer-reviewed journal for 10 years.
• Access Criteria: Signed MTA agreement between study sponsor and requesting entity.

Locations

US (1)