Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT01105169
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2010-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision-Based Magnesium Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-16', 'releaseDate': '2025-12-02'}, {'releaseDate': '2025-12-20'}], 'estimatedResultsFirstSubmitDate': '2025-12-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C091418', 'term': 'magnesium diglycinate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2010-04-14', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The protein expression levels of TRPM7, MLKL in colorectal mucosa', 'timeFrame': '12 week (rectal biopsies will be collected at the baseline and the end of the intervention)', 'description': 'TRPM7 and MLKL have been detected using immunohistochemical (IHC) techniques.'}, {'measure': 'Ratios of Ki67:BAX, Ki67:TUNEL (proliferation index) in rectal epithelial', 'timeFrame': '12 week (rectal biopsies will be collected at the baseline and the end of the intervention)', 'description': 'Ki67:BAX and Ki67:TUNEL have been analyzed using immunohistochemical (IHC) techniques.'}, {'measure': 'The expression of COX2 (inflammation) in rectal epithelia', 'timeFrame': '12 week (rectal biopsies will be collected at the baseline and the end of the intervention)', 'description': 'COX2 has been analyzed using immunohistochemical (IHC)'}, {'measure': 'The expression levels of apoptosis biomarkers (TUNEL and BAX) in colorectal mucosa', 'timeFrame': '12 week (rectal biopsies will be collected at the baseline and the end of the intervention)', 'description': 'TUNEL and BAX were analyzed using immunohistochemical (IHC)'}], 'secondaryOutcomes': [{'measure': 'Serum magnesium', 'timeFrame': '12 week', 'description': '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.'}, {'measure': 'Post treatment body magnesium status', 'timeFrame': '12 week after treatment', 'description': 'Body magnesium status obtained using magnesium tolerance test (MTT)'}, {'measure': 'Circulation 25-Hydroxyvitamin D', 'timeFrame': '12 week'}, {'measure': 'Serum C-reactive protein concentration', 'timeFrame': '12 week', 'description': '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'}]}, 'conditionsModule': {'keywords': ['Personalized prevention', 'Colorectal cancer', 'Investigational Nutrigenetic Studies', 'Magnesium', 'Gene polymorphism'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '40946805', 'type': 'DERIVED', 'citation': 'Sun E, Zhu X, Ness RM, Murff HJ, Sun S, Yu C, Fan L, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1185-1194. doi: 10.1016/j.ajcnut.2025.09.011. Epub 2025 Sep 12.'}, {'pmid': '40750038', 'type': 'DERIVED', 'citation': 'Sun S, Zhu X, Huang X, Yu C, Su T, Murff HJ, Ness RM, Azcarate-Peril MA, Shrubsole MJ, Dai Q. The Association of Gut Microbiota With TRPM7 Genotype, Colorectal Polyps, and Magnesium. J Nutr. 2025 Nov;155(11):3713-3725. doi: 10.1016/j.tjnut.2025.07.015. Epub 2025 Jul 30.'}, {'pmid': '36223712', 'type': 'DERIVED', 'citation': 'Fan L, Zhu X, Sun S, Yu C, Huang X, Ness R, Dugan LL, Shu L, Seidner DL, Murff HJ, Fodor AA, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Ca:Mg ratio, medium-chain fatty acids, and the gut microbiome. Clin Nutr. 2022 Nov;41(11):2490-2499. doi: 10.1016/j.clnu.2022.08.031. Epub 2022 Sep 12.'}, {'pmid': '34038556', 'type': 'DERIVED', 'citation': 'Fan L, Zhu X, Rosanoff A, Costello RB, Yu C, Ness R, Seidner DL, Murff HJ, Roumie CL, Shrubsole MJ, Dai Q. Magnesium Depletion Score (MDS) Predicts Risk of Systemic Inflammation and Cardiovascular Mortality among US Adults. J Nutr. 2021 Aug 7;151(8):2226-2235. doi: 10.1093/jn/nxab138.'}, {'pmid': '33487303', 'type': 'DERIVED', 'citation': 'Fan L, Yu D, Zhu X, Huang X, Murff HJ, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium and imidazole propionate. Clin Nutr ESPEN. 2021 Feb;41:436-438. doi: 10.1016/j.clnesp.2020.12.011. Epub 2021 Jan 7.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperplastic polyp or/and Adenoma cases\n* 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).\n* Participants from the TCPS (IRB # 090235), the TIARS (IRB # 090235), from Vanderbilt University Hospital or from other resources\n* Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)\n* Participants with a calcium intake ≥ 700 mg/day measuring with 24 hour dietary recalls\n* Participants with a calcium intake \\< 2000 mg/day measuring with 24 hour dietary recalls\n* Participants with a calcium/magnesium intake ratio \\> 2.6\n* Participants with known genotype for Thr1482Ile polymorphism in TRPM7\n* Will live in Nashville or surrounding area in the next 6 months\n\nExclusion Criteria:\n\n* Intolerance to magnesium glycinate or microcrystalline cellulose (placebo)\n* Chronic renal diseases and hepatic cirrhosis\n* Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months\n* Chronic diarrhea\n* Current breastfeeding\n* Current or planned pregnancy\n* Type I diabetes mellitus\n* Pituitary dwarfism\n* Use of digoxin and licorice\n* 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)\n* 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)\n* Individuals with a history of colon resection or colectomy due to any reason\n* Individuals with any history of cancer other than non-melanoma skin cancer\n* Individual with history of any organ transplantation\n* Individual with a history of gastric bypass due to any reason\n* Individuals with Inflammatory bowel disease\n* Individuals if creatinine clearance is \\< 50\n* Currently institutionalized\n* Homeless individual (address, telephone etc.)\n* Unable to provide informed consent\n* Any condition that in the opinion of the investigator raises concerns about protocol compliance'}, 'identificationModule': {'nctId': 'NCT01105169', 'briefTitle': 'Precision-Based Magnesium Trial', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Personalized Prevention of Colorectal Cancer Trial (PPCCT)', 'orgStudyIdInfo': {'id': '100106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GG genotype and magnesium treatment', 'description': 'Participants who have the GG genotype will be assigned to magnesium glycinate.', 'interventionNames': ['Dietary Supplement: Magnesium glycinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GG genotype and placebo', 'description': 'Participants who have the GG genotype will be assigned to placebo group', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GA/AA genotype and magnesium treatment', 'description': 'Participants who have the GA/AA genotype will be assigned to magnesium glycinate', 'interventionNames': ['Dietary Supplement: Magnesium glycinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GA/AA genotype and Placebo', 'description': 'Participants who have the GA/AA genotype will be assigned to placebo group', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Magnesium glycinate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of magnesium glycinate daily for 12 weeks', 'armGroupLabels': ['GA/AA genotype and magnesium treatment', 'GG genotype and magnesium treatment']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of identical-appearing placebo daily for 12 weeks', 'armGroupLabels': ['GA/AA genotype and Placebo', 'GG genotype and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Qi Dai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Chang Yu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Martha J Shrubsole, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qi Dai', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-02', 'type': 'RELEASE'}, {'date': '2025-12-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Qi Dai, Professor, Vanderbilt University Medical Center'}}}}