Vitamin D and the Host-Gut Microbiome: A Brief Overview.
Nuraly S Akimbekov, Ilya Digel, Dinara K Sherelkhan...
https://pubmed.ncbi.nlm.nih.gov/32624628Actively Recruiting
Phase Not Applicable
Age: 18Years - 69Years
All Genders
Healthy Volunteers
ID07199829
A Double-Blind Randomized Trial Evaluating Vitamin D3 and K2 Supplementation Effects on Inflammatory Markers and the Gut Microbiome in Healthcare Personnel
Led by Madigan Army Medical Center · Updated on 2025-09-30
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how supplemental vitamin D3 and vitamin K2 affect blood levels and the gut microbiome, the community of microbes in the gut. This study focuses on healthy adults with low vitamin D levels and looks at how genetic differences in vitamin metabolism may influence these effects. The research supports health promotion efforts and explores vitamin impacts on immune, bone, gut, and heart health, important for preventing chronic conditions. Participants will take one capsule daily for 90 days containing either vitamin D3 (125 mcg), vitamin K2 (180 mcg), a combination of both, or a placebo. The study is double-blind and randomized, comparing four groups. Over about 4 to 6 months, participants will have up to three visits for measurements including body composition, blood pressure, blood samples, and stool swabs. During the study, participants will complete questionnaires and provide samples on two occasions roughly 3 to 4 months apart. Researchers will assess changes in gut microbiome composition, richness, and diversity, along with blood markers such as serum 25-hydroxyvitamin D and osteocalcin. Genetic variations affecting vitamin metabolism will also be studied to understand their role in supplement response. The study includes monitoring lifestyle factors like physical activity and sleep to explore their relationship with vitamin and microbiome effects.
CONDITIONS
Brief Title
Evaluating Response to Vitamin D3 and K2 Supplementation in Healthcare Personnel
Who Can Participate
Age: 18Years - 69Years
All Genders
Healthy Volunteers
Eligibility Criteria
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 stop vitamin D3 and/or K2 supplements for 4.5 months
- Military beneficiary (Active Duty, Retired, Dependent)
- Plan to remain employed at workplace for 6 months
You will not qualify if you...
- Diagnosed medical condition preventing nutrient absorption (e.g., Inflammatory Bowel Disease, Celiac Disease, post-Roux-en-Y or Gastric sleeve surgery)
- Pregnant or breastfeeding
- Current antibiotic use or use within past 3 months
- Current anticoagulant use or use within past 3 months
- Use of weight loss or fat malabsorption medications (e.g., GLP-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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 90 days
Participants take vitamin D3, vitamin K2, a combination of both, or placebo supplements daily for 90 days to evaluate effects on inflammatory markers and the gut microbiome.
1 baseline visit and follow-up visits during supplementation
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
H
Hyojin C Yi, BSN
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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Published Research Related To This Trial
Genetic variants and associations of 25-hydroxyvitamin D concentrations with major clinical outcomes.
Gregory P Levin, Cassianne Robinson-Cohen, Ian H de Boer...
https://pubmed.ncbi.nlm.nih.gov/23150009Variability in response to vitamin D supplementation according to vitamin D metabolism related gene polymorphisms in healthy adults.
Mariem Ammar, Syrine Heni, Mohamed Sahbi Tira...
https://pubmed.ncbi.nlm.nih.gov/36167979