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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo intervention | Placebo Comparator | 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 |
|
| Vitamin D intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D intervention | Dietary Supplement | Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome alterations | Change in the microbiome structure and function | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen L Greathouse, PhD | Baylor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University | Waco | Texas | 76798 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39189761 | Derived | Wyatt M, Choudhury A, Von Dohlen G, Heileson JL, Forsse JS, Rajakaruna S, Zec M, Tfaily MM, Greathouse L. Randomized control trial of moderate dose vitamin D alters microbiota stability and metabolite networks in healthy adults. Microbiol Spectr. 2024 Oct 3;12(10):e0008324. doi: 10.1128/spectrum.00083-24. Epub 2024 Aug 27. |
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Study participant de-identified data will be shared with other researchers who submit a request for data acquisition. An MTA agreement will be constructed for protection of data sharing between the two researchers.
Data will become available at the time of publication in peer-reviewed journal for 10 years.
Signed MTA agreement between study sponsor and requesting entity.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2022 | May 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Double blind placebo controlled randomized intervention of vitamin supplementation
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Participants, investigators and outcomes assessors are masked to intervention group assignments using a researcher outside the study that maintains the study codes and IDs
| Placebo intervention | Dietary Supplement | Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |