Clinical trial · Interventional
Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults
Association of Vitamin D Supplementation and Normal Dietary Intake of Vitamin D With Changes in the Gut Microbiome and Markers of Colorectal Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo intervention | Dietary Supplement | — | UNRESOLVED |
| Vitamin D intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo intervention
- description
- 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
- interventionNames
- Dietary Supplement: Placebo intervention
- type
- EXPERIMENTAL
- label
- Vitamin D intervention
- description
- 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
- interventionNames
- Dietary Supplement: Vitamin D intervention
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Adult 18 years or older Exclusion Criteria: * Women who are currently pregnant or breastfeeding * Use of antibiotics within the last 2 weeks * Use of supplementary vitamin D within the last month * Self-reported, pre-existing history of inflammatory bowel disease, heart disease or diabetes * Students under 18 * Tanning/sun exposure \> 60 min at a time in last 4 weeks * No phenobarbital, carbamazepine, spironolactone chronic therapy; or steroid use within the last 2 weeks * Severe allergy to ingredients found in supplements
References
Publications (2)
- DERIVEDChoudhury A, Scano C, Barton A, Kearney CM, Greathouse KL. Precision Antimicrobial Therapy Against Fusobacterium nucleatum Using Bioengineered Probiotics Expressing Guided Antimicrobial Peptides (gAMPs). Microb Biotechnol. 2025 Dec;18(12):e70241. doi: 10.1111/1751-7915.70241. PMID 41368940
- DERIVEDWyatt 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. PMID 39189761