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

265 Participants Needed

Trial Summary

What is the purpose of this trial?

Colorectal cancer is the fourth most common incident cancer and the second most common cause of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths per year. High calcium intake and magnesium may protect against colorectal cancer and adenoma, however, results have been inconsistent. We found that genetic makeup, associated with magnesium absorption and re-absorption, significantly interacted with the calcium and magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who carried at least one 1482Ile allele (G-\>A)of TRPM7 and who consumed diets with a high calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were participants who did not carry the polymorphism. We hypothesize that the reduction in the dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary aims of this study are to conduct a randomized placebo-controlled intervention trial to test whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio may be more pronounced among those who carry the 1482Ile allele compared those who don't carry the 1482Ile allele. Results from our study will help to identify people at a high risk of colorectal adenoma and to develop personalized strategies to prevent occurrence of colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional fortification.

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.

What data supports the effectiveness of the treatment Magnesium glycinate for colorectal cancer?

Research suggests that magnesium might help reduce the risk of colorectal cancer by playing a role in cell metabolism and reducing inflammation. Some studies found that higher magnesium intake was linked to a lower risk of colorectal cancer, especially in overweight individuals. ^{1 2 3 4 5}

Is magnesium supplementation safe for humans?

Magnesium is generally considered safe for humans, and studies suggest it may even have protective effects against colorectal cancer. However, specific safety data for magnesium supplementation in clinical trials for colorectal cancer is not detailed in the available research. ^{1 2 3 6 7}

How does magnesium glycinate differ from other treatments for colorectal cancer?

Magnesium glycinate is unique because it is a highly absorbable form of magnesium, which may help reduce the risk of colorectal cancer by potentially offering a protective effect, as suggested by some studies. Unlike other treatments, it focuses on dietary supplementation rather than traditional cancer therapies like chemotherapy or radiation. ^{2 6 8 9 10}

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

Eligibility Criteria

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.

I have had a gastric bypass surgery in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Magnesium intake and colorectal tumor risk: a case-control study and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective Association of Serum and Dietary Magnesium with Colorectal Cancer Incidence. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Magnesium intake and colorectal cancer risk in the Netherlands Cohort Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Associations of intakes of magnesium and calcium and survival among women with breast cancer: results from Western New York Exposures and Breast Cancer (WEB) Study. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Association between magnesium intake and risk of colorectal cancer among postmenopausal women. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Magnesium intake and reduced risk of colon cancer in a prospective study of women. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Oral magnesium supplements for cancer treatment-induced hypomagnesemia: Results from a pilot randomized trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Inhibitory effect of magnesium hydroxide on methylazoxymethanol acetate-induced large bowel carcinogenesis in male F344 rats. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Bioavailability of magnesium diglycinate vs magnesium oxide in patients with ileal resection. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Association of hypomagnesemia with inferior survival in a phase III, randomized study of cetuximab plus best supportive care versus best supportive care alone: NCIC CTG/AGITG CO.17. [2022]