Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02759367
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Potassium Intake in Hypertensive Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Treating physicians and participants were not blinded to randomization. Investigators performing randomization and analysis of dietary intake were blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum potassium concentration', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': '24 hour urinary potassium excretion', 'timeFrame': '4 weeks'}, {'measure': '3 day dietary food diary', 'timeFrame': '4 weeks', 'description': 'Food record will assess marco and mirco nutrient intake.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Potassium'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '27581475', 'type': 'DERIVED', 'citation': 'Malta D, Arcand J, Ravindran A, Floras V, Allard JP, Newton GE. Adequate intake of potassium does not cause hyperkalemia in hypertensive individuals taking medications that antagonize the renin angiotensin aldosterone system. Am J Clin Nutr. 2016 Oct;104(4):990-994. doi: 10.3945/ajcn.115.129635. Epub 2016 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety of increasing dietary potassium intake in a hypertensive population that may be at risk for hyperkalemia.', 'detailedDescription': 'The blood pressure lowering benefits of increasing dietary potassium (K⁺) are well known. As such dietary recommendations for hypertension focus on a diet rich in high K⁺ food sources such as fruits and vegetables. An important theme to be addressed is the safety of achieving high dietary K⁺ intake in hypertensive individuals who are also receiving medical therapy that might predispose to elevated serum K⁺ levels (hyperkalemia).\n\nThe purpose of this study was to assess the impact of aggressively increasing dietary K⁺ on serum K⁺ concentrations in hypertensive individuals with intact renal function medicated with RAAS blocking drugs. The investigators hypothesized that dietary K⁺ supplementation would not provoke hyperkalemia despite treatment with either an angiotensin converting enzyme (ACEi) or an angiotensin receptor blocker (ARB).\n\nThe investigators conducted an open controlled clinical trial in 20 hypertensive subjects with normal renal function who were randomized to a usual diet group (UD n=10), or a high potassium diet group (HKD, n= 10). Fruits and vegetables were used to increase potassium intake. All participants were on an ACEi or and ARB. Serum potassium concentration, 3- day food records and 24 Hour urine collections were completed at baseline and at the end of the 4-week study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medically treated hypertension as diagnosed Hypertension was established by the participant's cardiologist or if recruited from the online community hypertension was self-reported and confirmed by study investigators based on participant's medical prescription.\n* Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous 3 months\n* K+ intake at baseline of less than 80 mmol/day (food diary of 24 hour food recall).\n\nExclusion Criteria:\n\n* Patients with an episode of acute coronary syndrome, or revascularization within the previous 3 months will not be included.\n* Serum K+ concentration 5.0 mmol/L\n* Serum creatinine \\> 130 mmol/L.\n* Inability to provide informed consent."}, 'identificationModule': {'nctId': 'NCT02759367', 'briefTitle': 'Increasing Potassium Intake in Hypertensive Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Adequate Intake of Potassium Does Not Cause Hyperkalemia in Hypertensive Individuals on Medications That Antagonize the Renin Angiotensin Aldosterone System', 'orgStudyIdInfo': {'id': 'MSH 08-0025-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High potassium diet group', 'description': 'Individuals in this arm were asked to increase dietary potassium intake over a 4 week period. This was achieved through an increase in consumption of fruits and vegetables.', 'interventionNames': ['Other: High potassium diet']}, {'type': 'NO_INTERVENTION', 'label': 'Usual diet group', 'description': 'Individuals in this group were asked to continue habitual dietary intake.'}], 'interventions': [{'name': 'High potassium diet', 'type': 'OTHER', 'description': 'An increase in consumption of high potassium fruits and vegetables', 'armGroupLabels': ['High potassium diet group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}