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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I know my genotype for a specific genetic variation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Circulation 25-Hydroxyvitamin D
Post treatment body magnesium status
Serum C-reactive protein concentration
+2 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
856 Previous Clinical Trials
671,927 Total Patients Enrolled
Qi Dai, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center
Martha J Shrubsole, Ph.D.Principal InvestigatorVanderbilt University Medical Center
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the prerequisites for participating in this experiment?
"Eligibility criteria for this medical trial necessitates that potential participants have colorectal carcinoma and are aged between 40 to 85. There is a target of 250 recruits in total."
Answered by AI
Does this trial's requirements stipulate a maximum age of 45?
"This medical trial seeks to recruit patients between the ages of 40 and 85. There are 38 studies that accept minors while those over 65 can participate in 1051 other investigations."
Answered by AI
Is this research presently accessible to participants?
"As indicated on clinicaltrials.gov, this medical trial is not currently open for recruitment as the last update was made in July of 2022. However, 1065 other studies are actively recruiting patients at present."
Answered by AI
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