VDMT: Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults
Study Details
Study Description
Brief Summary
Although dietary vitamin D supplementation has been used in the clinical setting for decades, the effect of supplementary vitamin D consumption on the structure of the microbiome has not been studied in humans in fine scale or with concomitant adjustment for dietary intake. Understanding the interaction of vitamin D with the microbiome in humans could lead to important advancements in the understanding of how vitamin D together with diet impacts the microbiome composition, and ultimately, risk of EOCRC. This study has the potential to lay the ground work for an adjunctive therapy to manipulate the microbiome to reduce risk of EOCRC. This proposed study is designed to evaluate the effect of vitamin D supplementation on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Placebo intervention A gummie candy the same consistency and nutrient value as the vitamin D gummie without any vitamin D will be taken as four gummies at the largest meal for 12 weeks once per day |
Dietary Supplement: Placebo intervention
Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks
|
Experimental: Vitamin D intervention A vitamin D gummie the same consistency and nutrient value as the placebo gummie will be taken as four gummies at the largest meal for 12 weeks once per day providing 4000 IUs per day or 1000 IUs per gummie |
Dietary Supplement: Vitamin D intervention
Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Microbiome alterations [12 weeks]
Change in the microbiome structure and function
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult 18 years or older
Exclusion Criteria:
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Women who are currently pregnant or breastfeeding
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Use of antibiotics within the last 2 weeks
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Use of supplementary vitamin D within the last month
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Self-reported, pre-existing history of inflammatory bowel disease, heart disease or diabetes
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Students under 18
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Tanning/sun exposure > 60 min at a time in last 4 weeks
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No phenobarbital, carbamazepine, spironolactone chronic therapy; or steroid use within the last 2 weeks
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Severe allergy to ingredients found in supplements
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Baylor University | Waco | Texas | United States | 76798 |
Sponsors and Collaborators
- Baylor University
Investigators
- Principal Investigator: Kristen L Greathouse, PhD, Baylor University
Study Documents (Full-Text)
More Information
Publications
None provided.- BaylorU-VDMT