Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
Study NCT ID:
NCT04229992
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2020-01-12
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation
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': 'Martha.shrubsole@vanderbilt.edu, qi.dai@vanderbilt.edu', 'phone': '(615)936-0707', 'title': 'Dr. Martha Shrubsole, 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': 'GG Genotype and Magnesium Treatment', 'description': 'Participants who have the GG genotype were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 1, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GG Genotype and Placebo', 'description': 'Participants who have the GG genotype were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 2, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GA/AA Genotype and Magnesium Treatment', 'description': 'Participants who have the GA/AA genotype were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 3, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'GA/AA Genotype and Placebo', 'description': 'Participants who have the GA/AA genotype were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 1, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding after the rectal biopsy procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feel sick', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Having an adverse effect on his blood pressure medication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain, migraine and swelling with arthritic pain in fingers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GG Genotype and Magnesium Treatment', 'description': 'Participants who have the GG genotype will be assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG001', 'title': 'GG Genotype and Placebo', 'description': 'Participants who have the GG genotype will be assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}, {'id': 'OG002', 'title': 'GA/AA Genotype and Magnesium Treatment', 'description': 'Participants who have the GA/AA genotype will be assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG003', 'title': 'GA/AA Genotype and Placebo', 'description': 'Participants who have the GA/AA genotype will be assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'classes': [{'title': 'Rectal Mucosa', 'categories': [{'measurements': [{'value': '0.108', 'spread': '2.268', 'groupId': 'OG000'}, {'value': '0.245', 'spread': '2.686', 'groupId': 'OG001'}, {'value': '-0.076', 'spread': '2.355', 'groupId': 'OG002'}, {'value': '0.132', 'spread': '2.034', 'groupId': 'OG003'}]}]}, {'title': 'Rectal Swab', 'categories': [{'measurements': [{'value': '-0.174', 'spread': '1.954', 'groupId': 'OG000'}, {'value': '-0.095', 'spread': '2.239', 'groupId': 'OG001'}, {'value': '-0.919', 'spread': '2.165', 'groupId': 'OG002'}, {'value': '0.364', 'spread': '2.111', 'groupId': 'OG003'}]}]}, {'title': 'Stool', 'categories': [{'measurements': [{'value': '-0.059', 'spread': '1.716', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '1.814', 'groupId': 'OG001'}, {'value': '0.363', 'spread': '1.276', 'groupId': 'OG002'}, {'value': '0.137', 'spread': '1.639', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': '1. GG genotype and magnesium treatment vs GG genotype and placebo;\n2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).', 'unitOfMeasure': 'percentage of sample', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Among participants with with rectal mucosa and rectal swab and stool samples.'}, {'type': 'PRIMARY', 'title': 'Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GG Genotype and Magnesium Treatment', 'description': 'Participants who have the GG genotype will be assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG001', 'title': 'GG Genotype and Placebo', 'description': 'Participants who have the GG genotype will be assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}, {'id': 'OG002', 'title': 'GA/AA Genotype and Magnesium Treatment', 'description': 'Participants who have the GA/AA genotype will be assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'OG003', 'title': 'GA/AA Genotype and Placebo', 'description': 'Participants who have the GA/AA genotype will be assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}], 'classes': [{'title': 'Rectal mucosa', 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '0.252', 'groupId': 'OG001'}, {'value': '0.039', 'spread': '0.208', 'groupId': 'OG002'}, {'value': '-0.025', 'spread': '0.196', 'groupId': 'OG003'}]}]}, {'title': 'Rectal swab', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.413', 'groupId': 'OG000'}, {'value': '-0.013', 'spread': '0.465', 'groupId': 'OG001'}, {'value': '-0.041', 'spread': '0.355', 'groupId': 'OG002'}, {'value': '-0.017', 'spread': '0.283', 'groupId': 'OG003'}]}]}, {'title': 'Stool', 'categories': [{'measurements': [{'value': '-0.063', 'spread': '0.536', 'groupId': 'OG000'}, {'value': '0.022', 'spread': '0.410', 'groupId': 'OG001'}, {'value': '-0.105', 'spread': '0.377', 'groupId': 'OG002'}, {'value': '0.084', 'spread': '0.418', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': '1. GG genotype and magnesium treatment vs GG genotype and placebo;\n2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).', 'unitOfMeasure': 'percentage of sample', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Among participants with with rectal mucosa and rectal swab and stool samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GG Genotype and Magnesium Treatment', 'description': 'Participants who have the GG genotype were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'FG001', 'title': 'GG Genotype and Placebo', 'description': 'Participants who have the GG genotype were assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}, {'id': 'FG002', 'title': 'GA/AA Genotype and Magnesium Treatment', 'description': 'Participants who have the GA/AA genotype were assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'FG003', 'title': 'GA/AA Genotype and Placebo', 'description': 'Participants who have the GA/AA genotype 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': '77'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', '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': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GG Genotype and Magnesium Treatment', 'description': 'Participants who have the GG genotype will be assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'BG001', 'title': 'GG Genotype and Placebo', 'description': 'Participants who have the GG genotype will be assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}, {'id': 'BG002', 'title': 'GA/AA Genotype and Magnesium Treatment', 'description': 'Participants who have the GA/AA genotype will be assigned to magnesium glycinate\n\nMagnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks'}, {'id': 'BG003', 'title': 'GA/AA Genotype and Placebo', 'description': 'Participants who have the GA/AA genotype will be assigned to placebo group\n\nPlacebo: Oral administration of identical-appearing placebo daily for 12 weeks'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '7.0', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '7.6', 'groupId': 'BG003'}, {'value': '60.7', 'spread': '7.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-08', 'size': 1257100, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-27T14:42', 'hasProtocol': True}]}}, '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': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2020-01-12', 'resultsFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2020-01-12', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-03', 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples', 'timeFrame': '12 weeks', 'description': 'changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).'}, {'measure': 'Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples', 'timeFrame': '12 weeks', 'description': 'changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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.'}]}, 'descriptionModule': {'briefSummary': 'Transient receptor potential melastatin 7 (TRPM7), a magnesium (Mg) -regulated chanzyme possessing both ion channel and kinase activities, has a much stronger affinity to Mg2+ than calcium (Ca)2+. We previously reported that individuals with the TRPM7 GA/AA genotype and consumed diets high in Ca:Mg ratio had an increased risk of colorectal polyps. The TRPM7 gene was also observed to possess "driver" mutations that contribute to developing multiple cancers. However, the molecular mechanism remains unclear.\n\nTo identify if the gut microbiota plays a role in this association, we will investigate whether optimizing Ca:Mg intake ratios to 2.3 altered the abundance of the microbes (e.g. associated with TRPM7 genotype and the risk of metachronous polyps) at the genus level in at least one sample type among stool, swab and tissue in a double-blind 2x2 factorial (TRPM7 genotype and Ca:Mg ratios) randomized trial (Personalized Prevention of Colorectal Cancer Trial, NCT01105169).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Participants from the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106)\n\nExclusion Criteria:\n\n• Participants did not provide any stool/swab/rectal biopsy sample in the parent study'}, 'identificationModule': {'nctId': 'NCT04229992', 'briefTitle': 'Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation', 'orgStudyIdInfo': {'id': '100106d'}, 'secondaryIdInfos': [{'id': 'R01DK110166', 'link': 'https://reporter.nih.gov/quickSearch/R01DK110166', 'type': 'NIH'}, {'id': 'R01CA149633', 'link': 'https://reporter.nih.gov/quickSearch/R01CA149633', 'type': 'NIH'}]}, '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': 'Martha Shrubsole, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Martha Shrubsole', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}