Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01074918
Status:
WITHDRAWN
Last Update Posted:
2019-02-11
First Post:
2010-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C066902', 'term': 'potassium-magnesium citrate'}, {'id': 'D011189', 'term': 'Potassium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017680', 'term': 'Potassium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'none enrolled per PI', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '8 weeks', 'description': 'We have estimated to detect a 4 mmHg difference, with a standard deviation estimated at 8 mmHg.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pre-hypertension', 'Hypertension'], 'conditions': ['Pre-hypertension', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 21 years\n* BMI \\> 18.5 kg/m2 and \\< 40 kg/m2\n* Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg\n* Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.\n\nExclusion Criteria:\n\n* Taking blood pressure lowering medication\n* Diabetes mellitus\n* Renal disease\n* Active cardiac disease\n* Active liver disease\n* Chronic diarrhea\n* Chronic NSAID use\n* Active or suspected drug use\n* Uncontrolled psychiatric disease\n* HIV infection\n* Missed more than 20% of clinic visits in the last yr\n* Prescription of diuretics for any reason\n* A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\\\\\n* Consumption of greater than 14 alcoholic beverages per week'}, 'identificationModule': {'nctId': 'NCT01074918', 'briefTitle': 'Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis', 'orgStudyIdInfo': {'id': '012007-080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Potassium Magnesium Citrate', 'interventionNames': ['Drug: Potassium, Magnesium, Citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Potassium Chloride', 'interventionNames': ['Drug: Potassium Chloride']}], 'interventions': [{'name': 'Potassium, Magnesium, Citrate', 'type': 'DRUG', 'description': 'Potassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water.', 'armGroupLabels': ['Potassium Magnesium Citrate']}, {'name': 'Potassium Chloride', 'type': 'DRUG', 'description': 'Potassium Chloride', 'armGroupLabels': ['Potassium Chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Orson Moe', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}