Colorectal CancerVDMTNCT05387876
Vitamin D Intervention and Associated Changes in the Gut Microbiome and Vitamin D Levels in Healthy Adults
A study testing Vitamin D intervention in people with Colorectal Cancer, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Vitamin D intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Vitamin D Supplementation and Normal Dietary Intake of Vitamin D With Changes in the Gut Microbiome and Markers of Colorectal Cancer Risk
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
- Colorectal Cancer
- Being tested
- Vitamin D intervention, Placebo intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D interventionDietary supplement
Nordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks
Placebo interventionDietary supplement
Organic gummie candies (no vitamin D), 4 gummies per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Placebo intervention |
| 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 Receives: Dietary Supplement: Vitamin D intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome alterations
Change in the microbiome structure and function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start14 Feb 2022
- Primary completion3 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled randomized intervention of vitamin supplementation
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen L Greathouse, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387876
- Sponsor's protocol ID
- BaylorU-VDMT
- Acronym
- VDMT
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Choudhury 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.
PubMed 41368940Wyatt 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.
PubMed 39189761
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Vitamin D Supplementation and Normal Dietary Intake of Vitamin D With Changes in the Gut Microbiome and Markers of Colorectal Cancer Risk
- ClinicalTrials.gov ID
- NCT05387876
- Acronym / sponsor ID
- VDMT / BaylorU-VDMT
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 3 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind placebo controlled randomized intervention of vitamin supplementation
| Arm | Type | Receives |
|---|---|---|
| Placebo intervention | Placebo comparator | Dietary Supplement: Placebo interventionA 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 | Dietary Supplement: Vitamin D interventionA 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult 18 years or older
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D interventionNordic Naturals vitamin D gummies (1000 IUs/gummie), 4 gummies per day for 12 weeks | Dietary supplement | Vitamin D intervention |
| Placebo interventionOrganic gummie candies (no vitamin D), 4 gummies per day for 12 weeks | Dietary supplement | Placebo intervention |
Primary outcome
Microbiome alterations
Time frame: 12 weeks
Change in the microbiome structure and function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 41368940Choudhury 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.
- Derived from this study: PubMed 39189761Wyatt 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen L Greathouse, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D intervention in people with Colorectal Cancer, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome alterations (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387876, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.