A Double-Blind Randomized Controlled Trial Evaluating Response to Vitamin D3 and K2 Supplementation Through Inflammatory Markers and the Gut Microbiome in Healthcare Personnel
Madigan Army Medical Center
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.
Description
Health promotion efforts for all branches of Service aim to ensure the health and readiness of the Force. This timely, relevant study supports this effort as well as the TriService Nursing Research Program priorities of Fit and Ready Force, Care for the Caregiver, and Translate Research into Practice. In 2023, the Defense Health Agency unveiled its strategic plan through 2028 which included these two priorities, 1) 'achieving new levels of excellence by fully leveraging emerging scientific and technological advancements to optimize the health and care experience of our beneficiaries', and 2) '…
Eligibility
- Age range
- 18–69 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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) * remaining employed at workplace for 6 months Exclusion Criteria: * 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 month…
Interventions
- Dietary SupplementVitamin Arm 1
Subject receives dietary supplement for 90 days
- Dietary SupplementVitamin Arm 2
Subject receives dietary supplement for 90 days
- Dietary SupplementVitamin Arm 3
Subject receives dietary supplement for 90 days
- OtherPlacebo
Subject receives placebo for 90 days
Location
- Madigan Army Medical CenterTacoma, Washington