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Investigational Nutrigenetic Studies for Cancer Prevention

40 Years
85 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Investigational Nutrigenetic Studies for Cancer Prevention

Inclusion Criteria:

- Adenoma cases from the TCPS study (IRB # 090235) or from Vanderbilt University

- Consent to be contacted for future studies in TCPS (IRB # 090235)

- Participants with a calcium intake ≥ 700 mg/day measuring with 24 hour dietary

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

- Participants with a calcium/magnesium intake ratio > 2.6

- Participants with known genotype for Thr1482Ile polymorphism in TRPM7

- Non African-American

- Will live in Nashville or surrounding area in the next 6 months

Exclusion Criteria:

- Intolerance to magnesium glycinate or microcrystalline cellulose (placebo)

- Chronic renal diseases and hepatic cirrhosis

- Chronic ischemic heart disease with unstable angina, chronic heart failure at class
III or IV and acute myocardial infarction in the last 6 months

- Chronic diarrhea

- Current breastfeeding

- Current or planned pregnancy

- Type I diabetes mellitus

- Pituitary dwarfism

- Use of digoxin and licorice

- Current use of blood anticoagulant drugs such as Dicumarol(Warfarin), Clopidogrel
(Plavix), Prasugrel HCl (Efficent), Ticlopidine (Ticlid), Lovenox (Enoxaparin),
Fragmin (Dalteparin), Innohep (Tinzaparin), Eptifibatide (Integrilin), Tyrofiban
(Aggrastat), and Abciximab (Reopro)

- Current use of lithium carbonate therapy (Eskalith, Lithobid, Lithonate, Lithotabs,
Apo-Lithium carbonate, Apo-Lithium carbonate SR, Carbolth, Duralith, PMS-Lithium
carbonate, PMS-Lithium citrate)

- 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

- Individuals with Inflammatory bowel disease

- Individuals if creatinine clearance is < 50

- Currently institutionalized

- Homeless individual (address, telephone etc.)

- Unable to provide informed consent

- Any condition that in the opinion of the investigator raises concerns about protocol

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

biomarkers directly related to tumorigenesis

Outcome Time Frame:

Assays of biomarkers will be performed at year 1, 2, 3, 4 and 5 of the study.

Safety Issue:


Principal Investigator

Qi Dai, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

March 2015

Related Keywords:

  • Colorectal Cancer
  • Personalized prevention
  • Colorectal cancer
  • Investigational Nutrigenetic Studies
  • Magnesium
  • Gene polymorphism
  • Colorectal Neoplasms



Vanderbilt Medical Center Nashville, Tennessee  37232-2765