Colorectal CancerNCT04229992

Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

A study testing Magnesium glycinate in people with Colorectal Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: Magnesium glycinate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 250 participants
Where: 1 siteUnited States
Study dates: 5 May 2017to 28 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants from the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106)

Who cannot join

Participants did not provide any stool/swab/rectal biopsy sample in the parent study

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37203

Other trials in United States

About this study

Transient receptor potential melastatin 7 (TRPM7), a magnesium (Mg) -regulated chanzyme possessing both ion channel and kinase activities, has a much stronger affinity to Mg2+ than calcium (Ca)2+. We previously reported that individuals with the TRPM7 GA/AA genotype and consumed diets high in Ca:Mg ratio had an increased risk of colorectal polyps. The TRPM7 gene was also observed to possess "driver" mutations that contribute to developing multiple cancers. However, the molecular mechanism remains unclear.

To identify if the gut microbiota plays a role in this association, we will investigate whether optimizing Ca:Mg intake ratios to 2.3 altered the abundance of the microbes (e.g. associated with TRPM7 genotype and the risk of metachronous polyps) at the genus level in at least one sample type among stool, swab and tissue in a double-blind 2x2 factorial (TRPM7 genotype and Ca:Mg ratios) randomized trial (Personalized Prevention of Colorectal Cancer Trial, NCT01105169).

Conditions: Colorectal Cancer
Being tested: Magnesium glycinate, Placebo
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium glycinateDietary supplement
Oral administration of magnesium glycinate daily for 12 weeks
PlaceboDietary supplement
Oral administration of identical-appearing placebo daily for 12 weeks

Study groups in NCT04229992
Study group	Role	What they receive
GG genotype and magnesium treatment	Active comparator	Participants who have the GG genotype will be assigned to magnesium glycinate Receives: Dietary Supplement: Magnesium glycinate
GG genotype and placebo	Placebo comparator	Participants who have the GG genotype will be assigned to placebo group Receives: Dietary Supplement: Placebo
GA/AA genotype and magnesium treatment	Active comparator	Participants who have the GA/AA genotype will be assigned to magnesium glycinate Receives: Dietary Supplement: Magnesium glycinate
GA/AA genotype and Placebo	Placebo comparator	Participants who have the GA/AA genotype will be assigned to placebo group Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples
changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).
Measured: 12 weeks
Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples
changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 201728 Mar 2024

First posted18 Jan 2020
Study start5 May 2017
Primary completion28 Feb 2024
Study completion28 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04229992
Sponsor's protocol ID: 100106d
Other IDs: R01DK110166, R01CA149633
Status last verified: Jan 2025
First submitted: 12 Jan 2020
Last updated: 28 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sun E, Zhu X, Ness RM, Murff HJ, Sun S, Yu C, Fan L, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1185-1194. doi: 10.1016/j.ajcnut.2025.09.011. Epub 2025 Sep 12.
PubMed 40946805

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation
ClinicalTrials.gov ID: NCT04229992
Acronym / sponsor ID: 100106d
Conditions: Colorectal Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
Study start: 5 May 2017 (actual)
Primary completion: 28 Feb 2024 (actual)
Study completion: 28 Mar 2024 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 28 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GG genotype and magnesium treatment	Active comparator	Dietary Supplement: Magnesium glycinateParticipants who have the GG genotype will be assigned to magnesium glycinate
GG genotype and placebo	Placebo comparator	Dietary Supplement: PlaceboParticipants who have the GG genotype will be assigned to placebo group
GA/AA genotype and magnesium treatment	Active comparator	Dietary Supplement: Magnesium glycinateParticipants who have the GA/AA genotype will be assigned to magnesium glycinate
GA/AA genotype and Placebo	Placebo comparator	Dietary Supplement: PlaceboParticipants who have the GA/AA genotype will be assigned to placebo group

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants from the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106)

Key exclusion criteria (1 listed)

Participants did not provide any stool/swab/rectal biopsy sample in the parent study

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
Magnesium glycinateOral administration of magnesium glycinate daily for 12 weeks	Dietary supplement	GA/AA genotype and magnesium treatment, GG genotype and magnesium treatment
PlaceboOral administration of identical-appearing placebo daily for 12 weeks	Dietary supplement	GA/AA genotype and Placebo, GG genotype and placebo

Primary outcome

Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples
Time frame: 12 weeks
changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).
Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples
Time frame: 12 weeks
changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).

Results and safety

Results posted to the registry on 28 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GG Genotype and Magnesium Treatment	77	76
GG Genotype and Placebo	78	75
GA/AA Genotype and Magnesium Treatment	47	43
GA/AA Genotype and Placebo	48	45

Primary outcome: Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples

Time frame: 12 weeks. Mean (Standard Error). Unit: percentage of sample

Measure	GG Genotype and Magnesium Treatment n = 73	GG Genotype and Placebo n = 70	GA/AA Genotype and Magnesium Treatment n = 42	GA/AA Genotype and Placebo n = 44
Rectal Mucosa	0.108 (2.268)	0.245 (2.686)	-0.076 (2.355)	0.132 (2.034)
Rectal Swab	-0.174 (1.954)	-0.095 (2.239)	-0.919 (2.165)	0.364 (2.111)
Stool	-0.059 (1.716)	-0.001 (1.814)	0.363 (1.276)	0.137 (1.639)

GG Genotype and Magnesium Treatment vs GG Genotype and Placebo vs GA/AA Genotype and Magnesium Treatment vs GA/AA Genotype and Placebo: p <0.05, Regression, Linear

Population analysed: Among participants with with rectal mucosa and rectal swab and stool samples.

Primary outcome: Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples

Time frame: 12 weeks. Mean (Standard Error). Unit: percentage of sample

Measure	GG Genotype and Magnesium Treatment n = 73	GG Genotype and Placebo n = 70	GA/AA Genotype and Magnesium Treatment n = 42	GA/AA Genotype and Placebo n = 44
Rectal mucosa	-0.030 (0.205)	-0.027 (0.252)	0.039 (0.208)	-0.025 (0.196)
Rectal swab	0.024 (0.413)	-0.013 (0.465)	-0.041 (0.355)	-0.017 (0.283)
Stool	-0.063 (0.536)	0.022 (0.410)	-0.105 (0.377)	0.084 (0.418)

GG Genotype and Magnesium Treatment vs GG Genotype and Placebo vs GA/AA Genotype and Magnesium Treatment vs GA/AA Genotype and Placebo: p <0.05, Regression, Linear

Population analysed: Among participants with with rectal mucosa and rectal swab and stool samples.

Adverse events

Time frame: In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GG Genotype and Magnesium Treatment	0 of 77 (0%)	1 of 77 (1.3%)	0 of 77
GG Genotype and Placebo	0 of 78 (0%)	2 of 78 (2.6%)	0 of 78
GA/AA Genotype and Magnesium Treatment	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47
GA/AA Genotype and Placebo	0 of 48 (0%)	1 of 48 (2.1%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40946805Sun E, Zhu X, Ness RM, Murff HJ, Sun S, Yu C, Fan L, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1185-1194. doi: 10.1016/j.ajcnut.2025.09.011. Epub 2025 Sep 12.

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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.

Martha Shrubsole, PhD principal investigator

Vanderbilt 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 Magnesium glycinate in people with Colorectal Cancer, run by Vanderbilt University Medical Center 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 1 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: finished, as of the sponsor's last update on 28 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04229992, which also lists 1 linked publication.

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 28 Jan 2025.