Actively Recruiting

Phase Not Applicable
Age: 18Years - 69Years
All Genders
Healthy Volunteers
NCT07199829

Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel

Led by Madigan Army Medical Center · Updated on 2025-09-30

96

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel

Who Can Participate

Age: 18Years - 69Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to read and understand English
  • 25 OHD serum level equal to or less than 30 ng/mL
  • Willing to discontinue vitamin D3 and/or K2 supplements for 4.5 months
  • Military beneficiary (Active Duty, Retired, Dependent)
  • Expected to remain employed at workplace for 6 months
Not Eligible

You will not qualify if you...

  • Diagnosed medical condition preventing nutrient absorption (e.g., Inflammatory Bowel Disease, Celiac Disease, post-Roux-en-Y/Gastric sleeve surgery)
  • Pregnant or breastfeeding
  • Current antibiotic use or use within past 3 months
  • Current anticoagulant use or use within past 3 months
  • Current weight loss or fat malabsorption medication use (e.g., Glucagon-Like Peptide 1 agonists, Orlistat)
  • Allergies or sensitivities to methylcellulose, vitamin D (D3, D2), or vitamin K (K2, Menaquinone-4, Menaquinone-7)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Madigan Army Medical Center

Tacoma, Washington, United States, 98431

Actively Recruiting

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Research Team

M

Mary S McCarthy, PhD

CONTACT

H

Hyojin C Yi, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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