Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=250 Randomized Triple-blind Prevention

Precision-Based Magnesium Trial

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01105169 ↗
Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo — 0.03; 0.08; -0.09; -0.11 log (arbitrary units) — p=>0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Magnesium glycinate (Dietary_supplement); Placebo (Dietary_supplement)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Dec 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo		 0.03; 0.08; -0.09; -0.11 >0.05
PRIMARY
COX2 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo		 0.10; 0.08; 0.11; -0.29 =0.05
PRIMARY
TUNEL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo		 0.24; 0.14; -0.09; -0.09 >0.05
PRIMARY
BAX Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo		 -0.03; -0.30; -0.18; -0.19 >0.05
PRIMARY
pMLKL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo		 0.11; 0.05; 0.02; -0.16 >0.05
PRIMARY
Ki67 Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo		 -0.11; 0.11; -0.03; -0.10 >0.05
SECONDARY
Serum Magnesium by Mg Treatment Compared With Placebo		 0.00; 0.00; 0.00; -0.10 <0.01 sig
SECONDARY
Post Treatment Body Magnesium Status by Mg Treatment and Placebo		 35.68; 41.58; 60.65; 42.24 >0.05
SECONDARY
Serum C-reactive Protein (CRP) by Mg Treatment Compared With Placebo		 0.04; -0.09; -0.47; -0.12 >0.05
SECONDARY
Urine Prostaglandin E2 Metabolite (PGE-M) by Mg Treatment Compared With Placebo		 -0.36; -0.24; 0.02; -0.25 >0.05

Summary

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.

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01105169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search