This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Personalized Prevention of Colorectal Cancer Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Qi Dai, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT01105169
First received: April 14, 2010
Last updated: August 10, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Colorectal Cancer Dietary Supplement: Magnesium glycinate Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigational Nutrigenetic Studies for Cancer Prevention

Resource links provided by NLM:


Further study details as provided by Qi Dai, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Rectal epithelial cell TRPM7 expression [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    The expression of TRPM7 is detected using immunohistochemical (IHC) techniques.

  • Rectal epithelial cell Cox2 expression [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    Expression of Cox2 in rectal epithelial will be analyzed using immunohistochemical (IHC) techniques.

  • Rectal epithelial cell apoptosis [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    The TUNEL (TdT-mediated dUTP Nick-End Labeling) assay is conducted to measure apoptosis of colon epithelium.

  • Rectal epithelial cell Bax expression [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    Expression of Bax in rectal epithelial will be analyzed using immunohistochemical (IHC) techniques.

  • Rectal epithelial cell proliferation [ Time Frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention) ]
    Expression of Ki-67 in colon epithelial cells will be analyzed using immunohistochemical (IHC) techniques.


Secondary Outcome Measures:
  • Serum 25-Hydroxyvitamin D [ Time Frame: 12 week ]
  • Serum magnesium [ Time Frame: 12 week ]
  • Serum C-reactive protein concentration [ Time Frame: 12 week ]

Enrollment: 250
Study Start Date: August 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GG genotype and magnesium treatment
Participants who have the GG genotype will be assigned to magnesium glycinate.
Dietary Supplement: Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks
Placebo Comparator: GG genotype and placebo
Participants who have the GG genotype will be assigned to placebo group
Dietary Supplement: Placebo
Oral administration of identical-appearing placebo daily for 12 weeks
Active Comparator: GA/AA genotype and magnesium treatment
Participants who have the GA/AA genotype will be assigned to magnesium glycinate
Dietary Supplement: Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks
Placebo Comparator: GA/AA genotype and Placebo
Participants who have the GA/AA genotype will be assigned to placebo group
Dietary Supplement: Placebo
Oral administration of identical-appearing placebo daily for 12 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 <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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105169

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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
  More Information

Responsible Party: Qi Dai, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01105169     History of Changes
Other Study ID Numbers: 100106
Study First Received: April 14, 2010
Last Updated: August 10, 2017

Keywords provided by Qi Dai, Vanderbilt University Medical Center:
Personalized prevention
Colorectal cancer
Investigational Nutrigenetic Studies
Magnesium
Gene polymorphism

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 21, 2017