Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT04196803
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2019-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ancillary Study of Methylation Biomarkers in a Randomized Controlled Trial of a Personalized Prevention of Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'qi.dai@vanderbilt.edu', 'phone': '615)936-0707', 'title': 'Dr. Qi Dai', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.', 'description': 'The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions.\n\nWe conducted safety and compliance calls to collect adverse event data.', 'eventGroups': [{'id': 'EG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 4, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 3, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'notes': 'abdominal pain, stomach hurt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding after the rectal biopsy procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feel sick', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritic pain in fingers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'notes': '10 pound weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Interaction with blood pressure medication', 'notes': 'may be having an adverse effect on blood pressure medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes of Cytosine Modification in TMPRSS2 (5-mC at cg16371860) by Magnesium Treatment Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Age<65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.022', 'groupId': 'OG001'}]}]}, {'title': 'Age≥65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.031', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value was calculated using general linear model adjusted for age, sex, and baseline level'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Increases in 5-mC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-mC methylation changes=value at 12 weeks minus value at baseline.', 'unitOfMeasure': 'units on CpG sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall analysis and stratified analysis by age (\\<65 years, ≥ 65 years)'}, {'type': 'SECONDARY', 'title': 'Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg16371860) by Magnesium Treatment Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Age<65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Age≥65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.002', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value was calculated using general linear model adjusted for age, sex, and baseline level'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Decreases in 5-hmC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-hmC methylation changes=value at 12 weeks minus value at baseline.', 'unitOfMeasure': 'units on CpG sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall analysis and stratified analysis by age (\\<65 years, ≥ 65 years)'}, {'type': 'SECONDARY', 'title': 'Changes of Cytosine Modification in TMPRSS2 (5-mC at cg26337277) by Magnesium Treatment Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Age<65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '-0.000', 'spread': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'Age≥65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.002', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value was calculated using general linear model adjusted for age, sex, and baseline level'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Increases in 5-mC methylation at cg26337277 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-mC methylation changes=value at 12 weeks minus value at baseline.', 'unitOfMeasure': 'units on CpG sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall analysis and stratified analysis by age (\\<65 years, ≥ 65 years)'}, {'type': 'SECONDARY', 'title': 'Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg26337277) by Magnesium Treatment Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Age<65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.001', 'groupId': 'OG001'}]}]}, {'title': 'Age≥65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.001', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.001', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value was calculated using general linear model adjusted for age, sex, and baseline level'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Decreases in 5-hmC methylation at cg26337277 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-hmC methylation changes=value at 12 weeks minus value at baseline.', 'unitOfMeasure': 'units on CpG sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall analysis and stratified analysis by age (\\<65 years, ≥ 65 years)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants, aged 40-85 y, with colorectal polyp or polyp-free individuals with high risk of colorectal cancer and had a calcium intake of ≥700 and \\<2000 mg/d, and their calcium-to-magnesium intake ratio was \\>2.6 (based on baseline two 24-hour dietary recalls) and have blood samples were recruited from Vanderbilt patient sources from March 11, 2011 to Jan 30, 2016 .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnesium Treatment', 'description': 'Participants were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-08', 'size': 3004309, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-28T08:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2019-12-10', 'resultsFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-21', 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Cytosine Modification in TMPRSS2 (5-mC at cg16371860) by Magnesium Treatment Versus Placebo', 'timeFrame': '12 Weeks', 'description': 'Increases in 5-mC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-mC methylation changes=value at 12 weeks minus value at baseline.'}], 'secondaryOutcomes': [{'measure': 'Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg16371860) by Magnesium Treatment Versus Placebo', 'timeFrame': '12 Weeks', 'description': 'Decreases in 5-hmC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-hmC methylation changes=value at 12 weeks minus value at baseline.'}, {'measure': 'Changes of Cytosine Modification in TMPRSS2 (5-mC at cg26337277) by Magnesium Treatment Versus Placebo', 'timeFrame': '12 Weeks', 'description': 'Increases in 5-mC methylation at cg26337277 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-mC methylation changes=value at 12 weeks minus value at baseline.'}, {'measure': 'Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg26337277) by Magnesium Treatment Versus Placebo', 'timeFrame': '12 Weeks', 'description': 'Decreases in 5-hmC methylation at cg26337277 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression.\n\n5-hmC methylation changes=value at 12 weeks minus value at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '34116393', 'type': 'BACKGROUND', 'citation': 'Fan L, Zhu X, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Yu C, Huang X, Shrubsole MJ, Hou L, Dai Q. Magnesium treatment on methylation changes of transmembrane serine protease 2 (TMPRSS2). Nutrition. 2021 Sep;89:111340. doi: 10.1016/j.nut.2021.111340. Epub 2021 May 7.'}, {'pmid': '34038556', 'type': 'BACKGROUND', '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': '32280092', 'type': 'BACKGROUND', 'citation': 'Zhu X, Borenstein AR, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Li B, Shrubsole MJ, Yu C, Hou L, Dai Q. Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial. J Alzheimers Dis. 2020;75(1):85-98. doi: 10.3233/JAD-191223.'}, {'pmid': '36223712', 'type': 'BACKGROUND', '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': '33487303', 'type': 'BACKGROUND', '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': 'Based on the magnesium tolerance test (MTT, "gold standard" for assessing magnesium (Mg) status), it was found that over 50% of participants in the US exhibited Mg deficiency. Studies suggest that the relationship between high Mg intake and disease risks may be varied by an individual\'s Mg status. Despite its importance, MTT is not commonly employed in routine clinical practice or research studies. Instead, serum Mg levels are typically used for clinical diagnosis, although this method has shown limited efficacy in identifying Mg deficiency accurately. Consequently, there is a pressing need to develop practical, sensitive, and specific biomarkers that can efficiently identify individuals with Mg deficiency.\n\nIt is known that DNA methylation changes are inducible by environmental exposures, including nutrients, and reversible when the exposure disappears. There are two major types of DNA methylation modifications, 5-hydroxymethylcytosine (5-hmC) and 5-methylcytosine (5-mC). 5-mC is often associated with suppressed gene expression. 5-hmC, generated by the oxidation of 5-mC, is specifically enriched in expressed genes and play a critical role in activating and/or maintaining gene expression. We plan identify 5-hmC and 5-mC for Mg deficiency by a 4- phase comprehensive epigenome-wide association study (EWAS) using the samples collected in the "Personalized Prevention of Colorectal Cancer Trial \\[PPCCT, R01CA149633; PI, Dai \\& Yu\\]" .\n\nThe parent trial \\[NCT04196023\\] that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of reducing the Ca:Mg ratio among those who consume high Ca:Mg ratio diets to decrease the risk of colorectal cancer. For this ancillary trial research, the investigators are examining ancillary measures of Changes of Cytosine Modification in TMPRSS2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);\n2. Participants consent to store/share biospecimens for future research.\n\nExclusion Criteria:\n\n1\\. Participants cannot provide their blood samples in the parent study.'}, 'identificationModule': {'nctId': 'NCT04196803', 'briefTitle': 'Ancillary Study of Methylation Biomarkers in a Randomized Controlled Trial of a Personalized Prevention of Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Methylomic Biomarkers, Magnesium Deficiency and Colon Neoplasia Prevention', 'orgStudyIdInfo': {'id': '100106c'}, 'secondaryIdInfos': [{'id': 'R01CA149633', 'link': 'https://reporter.nih.gov/quickSearch/R01CA149633', 'type': 'NIH'}, {'id': 'R01CA202936', 'link': 'https://reporter.nih.gov/quickSearch/R01CA202936', 'type': 'NIH'}, {'id': 'R01DK110166', 'link': 'https://reporter.nih.gov/quickSearch/R01DK110166', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'magnesium treatment', 'description': 'Participants were assigned to magnesium glycinate', 'interventionNames': ['Dietary Supplement: Magnesium glycinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Participants were 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': ['magnesium treatment']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of identical-appearing placebo daily for 12 weeks', 'armGroupLabels': ['placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Qi Dai', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}