๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-22

Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel (NCT07199829)

A Double-Blind Randomized Controlled Trial Evaluating Response to Vitamin D3 and K2 Supplementation Through Inflammatory Markers and the Gut Microbiome in Healthcare Personnel

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Madigan Army Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Madigan Army Medical Center โ€” Tacoma, Washington

Age range: 18 Years to 69 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Madigan Army Medical Center โ€” Tacoma, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: (253) 968-3695

Email: mary.s.mccarthy1.civ@health.mil

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—