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Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel

NCT07199829 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-09-30

No results posted yet for this study

Summary

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.

Conditions

  • Hypovitaminosis D
  • Hypovitaminosis

Interventions

DIETARY_SUPPLEMENT

Vitamin Arm 1

Subject receives dietary supplement for 90 days

DIETARY_SUPPLEMENT

Vitamin Arm 2

Subject receives dietary supplement for 90 days

DIETARY_SUPPLEMENT

Vitamin Arm 3

Subject receives dietary supplement for 90 days

OTHER

Placebo

Subject receives placebo for 90 days

Sponsors & Collaborators

  • Madigan Army Medical Center

    lead FED

Principal Investigators

  • Mary S McCarthy, PhD · Madigan AMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States

Study Locations

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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 NCT07199829 on ClinicalTrials.gov