Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 1:38 AM
Study NCT ID:
NCT04426994
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypomagnesemia Associated With Proton-Pump Inhibitor Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D006996', 'term': 'Hypocalcemia'}, {'id': 'D007008', 'term': 'Hypokalemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211672}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypomagnesemia due to use with proton pump inhibitor', 'timeFrame': '2013 to 2016', 'description': 'Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score'}], 'secondaryOutcomes': [{'measure': 'Risk factors for Hypomagnesemia', 'timeFrame': '2013 to 2016', 'description': 'Odds ratio of developing Hypomagnesemia with risk factors of age, gender, type of drug, dose of drug, chronic renal failure, use of diuretics'}, {'measure': 'Hypocalcaemia', 'timeFrame': '2013 to 2016', 'description': 'Number of patients developing hypocalcemia'}, {'measure': 'Hypokalemia', 'timeFrame': '2013 to 2016', 'description': 'Number of patients developing Hypokalemia'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proton Pump Inhibitor Adverse Reaction', 'Hypomagnesemia', 'Arrhythmias, Cardiac', 'Seizures', 'Hypocalcemia', 'Hypokalemia']}, 'descriptionModule': {'briefSummary': 'Use of proton pump inhibitors has been associated with hypomagnesemia. However, various case-control or prospective studies have found conflicting results with regards to proton pump inhibitors use and development of hypomagnesemia. Our aim was to evaluate the likelihood that proton pump inhibitors contributed to severe hypomagnesemia in a retrospective cohort of patients admitted with severe hypomagenesemia. We also aimed to look for risk factors leading to development of hypomagnesemia amongst users of proton pump inhibitors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients managed at a referral centre from 2013 - 2016. Cases were admitted to the referral centre and had documentation hypomagnesemia. Controls were prescribed a course of proton pump inhibitor during the same period', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted with hypomagnesemia (cases)\n* Patients prescribed with proton pump inhibitors (controls)\n\nExclusion Criteria:\n\n* Patients prescribed with less than three months duration of proton pump inhibitors (controls)'}, 'identificationModule': {'nctId': 'NCT04426994', 'acronym': 'PPI_HypoMg', 'briefTitle': 'Hypomagnesemia Associated With Proton-Pump Inhibitor Use', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Hypomagnesemia Associated With Proton-Pump Inhibitor Use', 'orgStudyIdInfo': {'id': 'PPI HypoMg'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Patients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use', 'interventionNames': ['Drug: proton pump inhibitor use']}, {'label': 'Control', 'description': 'Patients on long-term proton pump inhibitor without documented hypomagnesemia', 'interventionNames': ['Drug: proton pump inhibitor use']}], 'interventions': [{'name': 'proton pump inhibitor use', 'type': 'DRUG', 'description': 'Patients using long term proton pump inhibitor', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Troy H Puar, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymised pooled data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}