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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Vitamin Arm 1
Dietary supplementSubject receives dietary supplement for 90 days
Vitamin Arm 2
Dietary supplementSubject receives dietary supplement for 90 days
Vitamin Arm 3
Dietary supplementSubject receives dietary supplement for 90 days
Placebo
Other interventionSubject receives placebo for 90 days
Treatment groups
96 Participants
are divided into 4 treatment groupsGroup A: Vitamin Arm 1Active comparator 1 intervention
Group B: Vitamin Arm 2Active comparator 1 intervention
Group C: Vitamin Arm 3Active comparator 1 intervention
Group D: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gut microbiome composition
Evaluate effect of vitamin D3 and K2 dietary intake, and assigned vitamin supplementation group versus placebo group, on the gut microbiome composition
Time frame
90 days2
Gut microbiome richness
Will use Operational Taxonomic Units, Simpson Index and /or Chao1 index to evaluate gut microbiome richness before and after vitamin supplementation vs placebo
Time frame
90 days3
Gut microbiome diversity
Will use Operational Taxonomic Units, Simpson Index and /or Chao1 index to evaluate gut microbiome diversity before and after vitamin supplementation vs placebo
Time frame
90 daysSecondary outcomes
1
Serum 25OHD
Response to vitamin supplementation with serum 25(OH)D level pre and post supplement
Time frame
90 days2
Serum Osteocalcin level
Response to vitamin supplementation with serum osteocalcin level pre and post supplement
Time frame
90 days3
Vitamin D3 and K2 metabolic pathway variants on supplementation efficacy
Examine vitamin D3 and K2 metabolism pathway single nucleotide polymorphisms for effect on serum 25(OH)D and osteocalcin levels
Time frame
90 days4
Genetic and non-genetic factor contributions to gut microbiome composition
Explore relationships between diet, lifestyle behaviors (steps and sleep), body composition, metabolic and inflammatory serum biomarkers, and single nucleotide polymorphisms, and the gut microbiome
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov