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Hypovitaminosis DSupplementsNutrition and dietMicrobiomeGeneticsDietary supplement

What this study is

The main purpose of this research study is to learn about the effects of supplemental vitamin D3 and vitamin K2 on blood levels and the gut microbial community, called the gut microbiome. There are many influences on blood levels of vitamin D and K to include your dietary intake, lifestyle behaviors (physical activity, sleep), genetic alterations in metabolism of these vitamins, and the gut microbial abundance and diversity. You will be asked to take one capsule containing vitamin D3 (125 mcg), vitamin K2 (180 mcg), a combination of vitamins D3 and K2 (same doses as previous), or a placebo powder for 90 days. You will also be asked to complete questionnaires, undergo body composition and blood pressure measurements, provide blood samples and a stool swab, all on 2 occasions about 3 - 4 months apart. By conducting this study, we aim to identify the frequency of common genetic alterations in vitamins D and K metabolism and establish the impact on the gut microbiome for the first time. Your participation in this study will last about 4 - 6 months and include up to 3 visits.

What's being tested

  • Vitamin Arm 1

    Intervention · DIETARY SUPPLEMENT

  • Vitamin Arm 2

    Intervention · DIETARY SUPPLEMENT

  • Vitamin Arm 3

    Intervention · DIETARY SUPPLEMENT

  • Placebo

    Intervention · OTHER

    Subject receives placebo for 90 days

All of Vitamin Arm 1, Vitamin Arm 2, Vitamin Arm 3

Subject receives dietary supplement for 90 days

Study details

Official title
A Double-Blind Randomized Controlled Trial Evaluating Response to Vitamin D3 and K2 Supplementation Through Inflammatory Markers and the Gut Microbiome in Healthcare Personnel
Sponsor
Madigan Army Medical Center
Conditions
Hypovitaminosis D · Hypovitaminosis
Enrolling
96 people
Starts
2025-03-27
Est. completion
2026-03
Design
Quadruple-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗