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Precision-Based Magnesium Trial
Bu çalışma, kolorektal polip veya kanseri açısından yüksek riskli kişilerde magnezyum glisinat takviyesini plaseboyla karşılaştırıyor. Hiperplastik polip/adenomu olan ya da aile öyküsü, sigara, obezite gibi risk faktörleri taşıyan kişiler dahil edilmiştir. Faz uygulanmayan bir çalışmadır ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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