Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT00801034
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2008-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D011188', 'term': 'Potassium'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D019565', 'term': 'Metals, Light'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on blood pressure', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertension', 'potassium', 'blood pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22149452', 'type': 'DERIVED', 'citation': 'Matthesen SK, Larsen T, Vase H, Lauridsen TG, Pedersen EB. Effect of potassium supplementation on renal tubular function, ambulatory blood pressure and pulse wave velocity in healthy humans. Scand J Clin Lab Invest. 2012 Feb;72(1):78-86. doi: 10.3109/00365513.2011.635216. Epub 2011 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if the development of hypertension has a connection to our intake of potassium. We know that fruit and vegetables contain a lot of potassium and we will simulate this intake by giving healthy subjects potassium as tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* age 18-40 years old\n* BMI 18, 5-30\n* non-smoker\n\nExclusion Criteria:\n\n* daily use of medicine\n* alcohol or drugs\n* desire to become pregnant\n* not using safe anti-contraceptive\n* abnormal results in the initial testing'}, 'identificationModule': {'nctId': 'NCT00801034', 'briefTitle': 'The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'The Effects of Potassium on Physiological Variables in the Kidney and Cardiovascular Variables in Healthy Persons in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study', 'orgStudyIdInfo': {'id': 'MED.RES.HOS.2008.01.SKM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Calcium tablets', 'interventionNames': ['Drug: Calcium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Potassium tablets', 'interventionNames': ['Drug: Potassium']}], 'interventions': [{'name': 'Calcium', 'type': 'DRUG', 'description': 'tablets, 1 tablet 2 times per day in 28 days', 'armGroupLabels': ['1']}, {'name': 'Potassium', 'type': 'DRUG', 'description': 'Tablets, 5 tablets 2 times per day for 28 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'state': 'Holstebro', 'country': 'Denmark', 'facility': 'Department of medical research', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erling Bjerregaard Pedersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor, chief physician', 'investigatorFullName': 'Erling Bjerregaard Pedersen', 'investigatorAffiliation': 'Regional Hospital Holstebro'}}}}