Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorMadigan Army Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Diagnosed medical condition that prevents nutrient absorption from food (e.g. Inflammatory Bowel Disease, Celiac Disease, post-Roux-en-Y/Gastric sleeve surgery)

Pregnant or breastfeeding

Current antibiotic use or within past 3 months

Current anticoagulant use or within past 3 months

Trial design

Treatments tested in this trial

  • Vitamin Arm 1
  • Vitamin Arm 2
  • Vitamin Arm 3
  • Placebo

Treatment groups

96 Participants
are divided into 4 treatment groups

Sponsors and collaborators