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Mineral Supplement
Magnesium Supplementation for Colorectal Cancer
N/A
Waitlist Available
Led By Qi Dai, MD, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hyperplastic polyp or/and Adenoma cases
Participants with known genotype for Thr1482Ile polymorphism in TRPM7
Must not have
Chronic renal diseases and hepatic cirrhosis
Type I diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week
Summary
This trial will test whether reducing the amount of calcium relative to magnesium that a person consumes, through magnesium supplementation, has an effect on the related biomarkers of colorectal cancer.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from magnesium glycinate may include digestive issues like stomach upset or diarrhea. People intolerant to this compound cannot participate in the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a hyperplastic polyp or adenoma.
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I know my genotype for a specific genetic variation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chronic kidney disease or liver cirrhosis.
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I have Type 1 diabetes.
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I have had a gastric bypass surgery in the past.
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I have inflammatory bowel disease.
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I am unable to understand and give consent for treatment.
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I have not had a recent heart attack or severe heart failure.
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I am currently taking digoxin or licorice.
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I am currently taking lithium carbonate for my condition.
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I have long-term diarrhea.
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My kidney function, measured by creatinine clearance, is below 50.
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I am currently taking blood thinners.
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I have had surgery to remove part or all of my colon.
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I have had cancer before, but it was not non-melanoma skin cancer.
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I have had an organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Expression of Cox2 in rectal epithelia
Ratios of Ki67:BAX, Ki67:TUNEL in rectal epithelial
The protein expression levels of TRPM7, MLKL in colorectal mucosa
Secondary study objectives
Post treatment body magnesium status
Serum C-reactive protein concentration
Serum magnesium
+1 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: GA/AA genotype and magnesium treatmentActive Control1 Intervention
Participants who have the GA/AA genotype will be assigned to magnesium glycinate
Group II: GG genotype and magnesium treatmentActive Control1 Intervention
Participants who have the GG genotype will be assigned to magnesium glycinate.
Group III: GG genotype and placeboPlacebo Group1 Intervention
Participants who have the GG genotype will be assigned to placebo group
Group IV: GA/AA genotype and PlaceboPlacebo Group1 Intervention
Participants who have the GA/AA genotype will be assigned to placebo group
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
904 Previous Clinical Trials
933,814 Total Patients Enrolled
Qi Dai, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center
Martha J Shrubsole, Ph.D.Principal InvestigatorVanderbilt University Medical Center
Chang Yu, PhDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for colorectal issues due to family history, smoking, obesity, low fiber diet, or high red meat intake.I have chronic kidney disease or liver cirrhosis.I have Type 1 diabetes.I have had a gastric bypass surgery in the past.I have inflammatory bowel disease.I am unable to understand and give consent for treatment.I have not had a recent heart attack or severe heart failure.I am currently taking digoxin or licorice.I am currently taking lithium carbonate for my condition.You have a condition called pituitary dwarfism.I have long-term diarrhea.My kidney function, measured by creatinine clearance, is below 50.I am currently taking blood thinners.You are currently breastfeeding a baby.I have been diagnosed with a hyperplastic polyp or adenoma.I have had surgery to remove part or all of my colon.I know my genotype for a specific genetic variation.I have had cancer before, but it was not non-melanoma skin cancer.I have had an organ transplant.You have had allergic reactions or bad side effects from taking magnesium glycinate or microcrystalline cellulose, which is a fake treatment (placebo).
Research Study Groups:
This trial has the following groups:- Group 1: GG genotype and placebo
- Group 2: GA/AA genotype and Placebo
- Group 3: GA/AA genotype and magnesium treatment
- Group 4: GG genotype and magnesium treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.