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Completed

NCT Number: NCT01105169

Precision-Based Magnesium 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (BMI≥30 kg/m2); (4) low intake of fiber (lowest fiber intake quartile: daily intake <16.6g); (5) high intake of red meat and well-done or processed meat (mutageneity index ≥5852).
  • Participants from the TCPS (IRB # 090235), the TIARS (IRB # 090235), from Vanderbilt University Hospital or from other resources
  • Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)
  • 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 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
  • Individual with a history of gastric bypass due to any reason
  • 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 compliance

Treatment and study plan

Magnesium glycinate

Dietary Supplement

Oral administration of magnesium glycinate daily for 12 weeks

Placebo

Dietary Supplement

Oral administration of identical-appearing placebo daily for 12 weeks

Primary outcomes

  1. TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 weeks

    Transient Receptor Potential Melastatin 7 (TRPM7) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. .

    Changes (posttreatment-baseline) of TRPM7=log(value at 12 weeks) minus log(value at baseline).

  2. COX2 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Cyclooxygenase (COX2) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. .

    Changes (posttreatment-baseline) of COX2=log(value at 12 weeks) minus log(value at baseline).

  3. TUNEL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Terminal Deoxynucleotidyl Transferase dUTP Nick End Labeling (TUNEL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and computed as count of apoptotic cells/mm2 of epithelial cell nuclei area (cells/mm²).

    Changes (posttreatment-baseline) of TUNEL =log(value at 12 weeks) minus log(value at baseline).

  4. BAX Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    BCL2-associated X (BAX) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining.

    Changes (posttreatment-baseline) of BAX=log(value at 12 weeks) minus log(value at baseline).

  5. pMLKL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Phosphorylated Mixed Lineage Kinase Like (pMLKL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining.

    Changes (posttreatment-baseline) of pMLKL=log(value at 12 weeks) minus log(value at baseline).

  6. Ki67 Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Ki67 levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and calculated as positive nuclei area / epithelial cell nuclei area * 100 (%).

    Changes (posttreatment-baseline) of Ki67=log(value at 12 weeks) minus log(value at baseline).

Secondary outcomes

  1. Serum Magnesium by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Changes (posttreatment-baseline) of serum magnesium (measured continuously using 7D70 Magnesium Reagent Kit from Abbot Laboratories (Abbott Park, IL) )

  2. Post Treatment Body Magnesium Status by Mg Treatment and Placebo

    Time frame: At week 12

    Post treatment body magnesium status obtained using magnesium tolerance test (MTT)

    Mg retention rate (%)=[1-(post-infusion Mg excretion - pre-infusion Mg excretion) / total Mg infused]*100.

  3. Serum C-reactive Protein (CRP) by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Changes (posttreatment-baseline) of CRP (measured continuously using turbidimetric immunoassay (Pointe Scientific, Inc, Canton, MI)

  4. Urine Prostaglandin E2 Metabolite (PGE-M) by Mg Treatment Compared With Placebo

    Time frame: Baseline to 12 week

    Changes (posttreatment-baseline) of PGE-M (measured continuously using a liquid chromatography/tandem mass spectrometric method).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Personalized Prevention of Colorectal Cancer Trial (PPCCT)

Important dates

Study start
2011
Primary completion
2024
Study completion
2025
First posted
Apr 16, 2010
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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