RECRUITING

Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-27
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07199829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 69 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * able to read and understand English
  2. * 25 OHD serum level equal to or less than 30 ng/mL
  3. * willing to discontinue vitamin D3 and/or K2 supplements for 4.5 months
  4. * military beneficiary (Active Duty, Retired, Dependent)
  5. * remaining employed at workplace for 6 months
  1. * Diagnosed medical condition that prevents nutrient absorption from food (e.g. Inflammatory Bowel Disease, Celiac Disease, post-Roux-en-Y/Gastric sleeve surgery)
  2. * Pregnant or breastfeeding
  3. * Current antibiotic use or within past 3 months
  4. * Current anticoagulant use or within past 3 months
  5. * Current weight loss or fat malabsorption medication use (e.g. Glucagon-Like Peptide 1 agonists, Orlistat)
  6. * Allergies or sensitivities to methylcellulose, vitamin D (D3, D2), or vitamin K (K2, Menaquinone-4, Menaquinone-7)

Contacts and Locations

Study Contact

Mary S McCarthy, PhD
CONTACT
253-968-3695
mary.s.mccarthy1.civ@health.mil
Hyojin C Yi, BSN
CONTACT
253-968-2898
hyojin.c.yi.ctr@health.mil

Principal Investigator

Mary S McCarthy, PhD
PRINCIPAL_INVESTIGATOR
Madigan AMC

Study Locations (Sites)

Madigan Army Medical Center
Tacoma, Washington, 98431
United States

Collaborators and Investigators

Sponsor: Madigan Army Medical Center

  • Mary S McCarthy, PhD, PRINCIPAL_INVESTIGATOR, Madigan AMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-27
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Hypovitaminosis D
  • Hypovitaminosis K
  • Gut microbiome

Additional Relevant MeSH Terms

  • Hypovitaminosis D
  • Hypovitaminosis