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Precision-Based Magnesium Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01105169
Recruitment Status : Active, not recruiting
First Posted : April 16, 2010
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
Qi Dai, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE April 14, 2010
First Posted Date  ICMJE April 16, 2010
Last Update Posted Date July 14, 2022
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • The protein expression levels of TRPM7, MLKL in colorectal mucosa [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    TRPM7 and MLKL have been detected using immunohistochemical (IHC) techniques.
  • Ratios of Ki67:BAX, Ki67:TUNEL in rectal epithelial [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    Ki67:BAX and Ki67:TUNEL have been analyzed using immunohistochemical (IHC) techniques.
  • Expression of Cox2 in rectal epithelia [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    Cox2 has been analyzed using immunohistochemical (IHC)
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
biomarkers directly related to tumorigenesis [ Time Frame: Assays of biomarkers will be performed at year 1, 2, 3, 4 and 5 of the study. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • Serum magnesium [ Time Frame: 12 week ]
    Serum magnesium concentration was determined using 7D70 Magnesium Reagent Kit from Abbot Laboratories (Abbott Park, IL) the assay was conducted at the Vanderbilt Pathology Laboratory Services.
  • Post treatment body magnesium status [ Time Frame: 12 week after treatment ]
    Body magnesium status obtained using magnesium tolerance test (MTT)
  • Circulation 25-Hydroxyvitamin D [ Time Frame: 12 week ]
  • Serum C-reactive protein concentration [ Time Frame: 12 week ]
    Assays of CRP for 180 participants were performed using immuno turbidimetric immunoassay based commercial assay kits (Pointe Scientific, Inc, Canton, MI) at Vanderbilt Lipid Laboratory
  • Urine excretion of prostaglandin E2 metabolite (PGE-M) [ Time Frame: 12 week ]
    Urinary PGE-M level was measured using a liquid chromatography/tandem mass spectrometric method at the Integrated Health Sciences Facility Core of the Vanderbilt Center in Molecular Toxicology.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Precision-Based Magnesium Trial
Official Title  ICMJE Personalized Prevention of Colorectal Cancer Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Dietary Supplement: Magnesium glycinate
    Oral administration of magnesium glycinate daily for 12 weeks
  • Dietary Supplement: Placebo
    Oral administration of identical-appearing placebo daily for 12 weeks
Study Arms  ICMJE
  • Active Comparator: GG genotype and magnesium treatment
    Participants who have the GG genotype will be assigned to magnesium glycinate.
    Intervention: Dietary Supplement: Magnesium glycinate
  • Placebo Comparator: GG genotype and placebo
    Participants who have the GG genotype will be assigned to placebo group
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: GA/AA genotype and magnesium treatment
    Participants who have the GA/AA genotype will be assigned to magnesium glycinate
    Intervention: Dietary Supplement: Magnesium glycinate
  • Placebo Comparator: GA/AA genotype and Placebo
    Participants who have the GA/AA genotype will be assigned to placebo group
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
250
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2010)
240
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01105169
Other Study ID Numbers  ICMJE 100106
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Qi Dai, Vanderbilt University Medical Center
Original Responsible Party Qi Dai, Assistant Professor, Vanderbilt University
Current Study Sponsor  ICMJE Vanderbilt University Medical Center
Original Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qi Dai, MD, PhD Vanderbilt University Medical Center
Principal Investigator: Chang Yu, PhD Vanderbilt University Medical Center
Principal Investigator: Martha J Shrubsole, Ph.D. Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP