Magnesium Supplementation for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants, Lithium, Digoxin, Licorice

Disqualifiers: Chronic renal, Heart disease, Pregnancy, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnesium supplements, specifically magnesium glycinate, can reduce the risk of colorectal polyps and cancer by altering certain body markers. Researchers aim to determine if lowering the calcium-to-magnesium ratio in the diet benefits individuals with a specific genetic trait (1482Ile allele). The trial includes different groups based on participants' genetics to assess magnesium's effects on those with and without the trait. Suitable candidates for this trial may include individuals with a family history of colorectal issues, current smokers, or those who consume a lot of red meat but little fiber. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new dietary recommendations for colorectal health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including blood thinners like Warfarin and Plavix, and lithium carbonate therapy. If you are on these medications, you would need to stop them to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that magnesium supplements might be safe and beneficial for people at risk of colorectal cancer. Studies suggest that magnesium could reduce this risk by boosting certain gut bacteria that help produce vitamin D, which is known to protect against cancer.

The trial uses magnesium glycinate, a form that is usually gentle on the stomach. Some participants might experience mild side effects like an upset stomach or diarrhea, but serious issues are rare. Magnesium glycinate is also found in other health supplements, supporting its safety.

For concerns about how magnesium might affect you, consult your doctor. This will help you make an informed decision about joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about magnesium glycinate as a potential treatment for colorectal cancer because it offers a novel approach compared to traditional options like chemotherapy and radiation. Unlike these standard treatments, which often come with significant side effects, magnesium glycinate is a dietary supplement that could support cancer treatment with fewer adverse effects. It works by potentially influencing cellular processes involved in cancer progression, offering a gentler alternative that could be used alongside existing therapies. This opens the door to more personalized treatment strategies, particularly for individuals with specific genetic profiles, making it a promising area of exploration in cancer therapy.

What evidence suggests that magnesium supplementation might be an effective treatment for colorectal cancer?

This trial will compare magnesium supplementation with a placebo to assess its impact on colorectal cancer risk. Studies have shown that magnesium supplements may lower the risk of colorectal cancer, especially in individuals with certain genetic traits affecting magnesium absorption. Research suggests that magnesium can promote the growth of beneficial gut bacteria, which produce vitamin D and may help prevent cancer. For those with a genetic variant affecting magnesium processing, taking magnesium has reduced cancer risk. Additionally, consuming more magnesium-rich foods has been linked to a lower chance of developing colorectal cancer, particularly in postmenopausal women. These findings suggest that magnesium could be a helpful way to reduce colorectal cancer risk for some individuals. ^{1 2 4 6 7}

Who Is on the Research Team?

Qi Dai, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Martha J Shrubsole, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Chang Yu, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults at high risk of colorectal polyps or cancer due to family history, smoking, obesity, low fiber intake, or high red meat consumption. Participants must not have a history of any cancer (except non-melanoma skin), organ transplants, gastric bypasses, certain heart conditions, chronic diarrhea or diabetes type I. They should live near Nashville for the next 6 months and agree to genetic testing.

Inclusion Criteria

I am at high risk for colorectal issues due to family history, smoking, obesity, low fiber diet, or high red meat intake.

Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary recalls

Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)

Exclusion Criteria

I have chronic kidney disease or liver cirrhosis.

I have Type 1 diabetes.

Currently institutionalized

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive magnesium supplementation or placebo to test the effects on biomarkers related to colorectal cancer

12 weeks

Baseline and end of intervention visits for rectal biopsies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium glycinate
• Placebo

Trial Overview The study tests if magnesium glycinate supplements can affect biomarkers related to colorectal tumorigenesis by altering the dietary calcium/magnesium ratio. It's especially focused on individuals with a specific gene variant (1482Ile allele). Participants are randomly assigned to receive either magnesium glycinate or a placebo.

How Is the Trial Designed?

Group I: GA/AA genotype and magnesium treatment Active Control 1 Intervention

Participants who have the GA/AA genotype will be assigned to magnesium glycinate

Group II: GG genotype and magnesium treatment Active Control 1 Intervention

Participants who have the GG genotype will be assigned to magnesium glycinate.

Group III: GG genotype and placebo Placebo Group 1 Intervention

Participants who have the GG genotype will be assigned to placebo group

Group IV: GA/AA genotype and Placebo Placebo Group 1 Intervention

Participants who have the GA/AA genotype will be assigned to placebo group

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0002916525005271

Magnesium treatment increases gut microbiome ... Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision- ...

2. news.vumc.org news.vumc.org/2025/09/12/study-shows-magnesium-inhibits-colorectal-cancer-carcinogenesis-by-increasing-vitamin-d-synthesizing-bacteria/

Study shows magnesium inhibits colorectal cancer ... The findings suggest that magnesium supplementation treatment may decrease colorectal cancer risk in individuals with inadequate TRPM7 function.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40946805/

Magnesium Treatment Increases Gut Microbiome ... Magnesium Treatment Increases Gut Microbiome Synthesizing Vitamin D and Inhibiting Colorectal Cancer: Results from a Double-Blind Precision-based Randomized ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01105169

NCT01105169 | Precision-Based Magnesium Trial High calcium intake and magnesium may protect against colorectal cancer and adenoma, however, results have been inconsistent.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11351748/

Magnesium Ion: A New Switch in Tumor Treatment - PMC A higher magnesium intake in the diet (400 mg/day) has been shown to reduce the incidence of colorectal cancer in postmenopausal women, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3320715/

Calcium, Magnesium, and Colorectal Cancer - PMC Intake of calcium may be associated with a decreased risk of colorectal adenoma only when the dietary calcium:magnesium intake ratio is low.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2017-01651

Magnesium Glycinate in Preventing Colorectal ... Reducing the dietary calcium to magnesium ratio may lower risk of polyp recurrence and colorectal cancer.