Magnesium Glycinate in Preventing Colorectal Cancer in Patients with Colorectal Hyperplastic Polyp or Adenoma
This randomized clinical trial studies how well magnesium glycinate works in preventing colorectal cancer in patients with colorectal hyperplastic polyp or adenoma. Reducing the dietary calcium to magnesium ratio may lower risk of polyp recurrence and colorectal cancer.
Inclusion Criteria
- Hyperplastic polyp or/and adenoma cases
- Polyps free participants with any of the following high risk of colorectal polyps or cancer: (1) family history of colorectal cancer or polyps; (2) current cigarette smoker; (3) obesity (body mass index [BMI] >= 30 kg/m^2); (4) low intake of fiber (lowest fiber intake quartile: daily intake < 16.6 g); (5) high intake of red meat and well-done or processed meat (mutagenicity index >= 5852)
- Consent to be contacted for future studies
- Participants with a calcium intake >= 700 mg/day measuring with 24 hour dietary recalls
- Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary recalls
- Participants with a calcium/magnesium intake ratio > 2.6
- Participants with known genotype for Thr1482Ile polymorphism in TRPM7
- Will live in Nashville or surrounding area for the next 6 months
- No history of Inflammatory bowel disease
Exclusion Criteria
- Intolerance to magnesium glycinate or microcrystalline cellulose (placebo)
- Current breastfeeding
- Current or planned pregnancy
- Chronic renal diseases and hepatic cirrhosis
- Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV, and myocardial infarction in the last 6 months
- Chronic diarrhea
- Type I diabetes mellitus
- Pituitary dwarfism
- Individuals with a history of colon resection or colectomy due to any reason
- Individuals with any history of cancer other than non-melanoma skin cancer
- Individual with history of any organ transplantation
- Individual with history of gastric bypass due to any reason
- Use of digoxin and licorice
- Current use of blood anticoagulant drugs such as dicumarol (Warfarin), clopidogrel (Plavix), prasugrel hydrochloride (HCl) (Effient), ticlopidine (Ticlid), Lovenox (Enoxaparin), Fragmin (Dalteparin), Innohep (Tinzaparin), eptifibatide (Integrilin), tirofiban (Aggrastat), and abciximab (ReoPro)
- Current use of lithium carbonate therapy (Eskalith, Lithobid, Lithonate, Lithotabs, Apo-Lithium carbonate, Apo-Lithium carbonate SR, Carbolith, Duralith, PMS-Lithium carbonate, PMS-Lithium citrate)
- Individuals with inflammatory bowel disease
- Individuals if creatinine clearance is < 50
- Currently institutionalized
- Homeless individuals (address, telephone etc.)
- Unable to provide informed consent
- Any condition that in the opinion of the investigator raises concerns about protocol compliance
Additional locations may be listed on ClinicalTrials.gov for NCT01105169.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Conduct a randomized intervention trial (120 patients in each treatment or placebo arm) to evaluate the main effect of reducing the dietary calcium (Ca)/magnesium (Mg) intake ratio to under 2.6 by magnesium supplementation on increasing the expression of apoptosis biomarkers (e.g. TUNEL and Bax) and reducing expression of TRPM7/TRPM6, COX-2 (inflammation) and Ki-67 (proliferation index) in colorectal mucosa as well as to reduce urinary excretion of prostaglandin E2 metabolite (PGE-M) and increasing total erythrocyte magnesium and body magnesium store (magnesium tolerance test).
II. Conduct a randomized intervention trial (120 patients in each treatment or placebo arm) to evaluate the main effect of reducing the dietary calcium (Ca)/magnesium (Mg) intake ratio to under 2.6 by magnesium supplementation on increasing serum levels of magnesium and vitamin D and reducing plasma concentration of C-reactive protein.
III. Evaluate the interaction between magnesium treatment and the Thr1482Ile polymorphism (glycine [G] to alanine [A]).
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive magnesium glycinate orally (PO) once daily (QD) for 12 weeks in the absence of disease progression or unaccepted toxicity.
ARM II: Patients receive placebo PO QD for 12 weeks in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up for 5 years.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorQi Dai
- Primary IDVICC GI 99003
- Secondary IDsNCI-2017-01651
- ClinicalTrials.gov IDNCT01105169