Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-26 @ 4:21 PM
Study NCT ID:
NCT00282659
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2006-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2006-01-25', 'studyFirstSubmitQcDate': '2006-01-25', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose', 'timeFrame': 'at baseline, 3, and 6 months of follow-up'}]}, 'conditionsModule': {'keywords': ['Hemodynamics', 'Hypertension', 'Dyslipidemia', 'Diabetes', 'Implantable Cardioverter Defibrillator', 'Blood Pressure'], 'conditions': ['Coronary Artery Disease', 'Hypertension', 'Dyslipidemia', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).', 'detailedDescription': 'Magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. It has been determined that patients with cardiovascular disease have intracellular magnesium (Mgi) deficiencies. Among the ICD registries in Europe and the United States 64% and 77% of patients also carry the diagnosis of CAD, respectively. Patients with CAD have risk factors that lead to the development and or propagation of atherosclerosis. Paramount among these risk factors are hypertension, dyslipidemia, and diabetes.\n\nComparison: Magnesium compared to placebo in patients with ICDs to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly implanted ICD or recent ICD shock (within 6 months)\n\nExclusion Criteria:\n\n* Inability to swallow\n* A non-cardiac disease with a survival prognosis of less than 12 months\n* Hypermagnesemia\n* Creatinine clearance less than 30mL/min\n* Lactic acidosis or systemic acidosis syndrome\n* Previous intolerance to magnesium L-lactate'}, 'identificationModule': {'nctId': 'NCT00282659', 'briefTitle': 'The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'The Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag', 'orgStudyIdInfo': {'id': 'WHIT001799HI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'magnesium L-lactate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102-5037', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Charles M White, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}