Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT00590512
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2007-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Salt Intake and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2007-12-28', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': 'one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dietary salt', 'sodium', 'blood vessels', 'vascular function', 'endothelial function', 'heart disease risk', 'cardiovascular disease risk'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.', 'detailedDescription': 'Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male, African-American volunteers\n2. 18-35 years of age,\n3. No personal or first degree relative with hypertension or diabetes,\n4. Blood pressure \\<130/85 mmHg and \\> 90/60 at the screening visit,\n5. Body mass index \\<30 kg/m2,\n6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).\n\nExclusion Criteria:\n\n1. Alcohol intake \\>2 beverage/night,\n2. Smoking,\n3. Recreational drug use,\n4. Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,\n5. Prescription or herbal medication use,\n6. Ischemic changes on resting electrocardiogram,\n7. Known hypersensitivity to any of the study drugs,\n8. Other active medical problems detected by examination or laboratory testing.'}, 'identificationModule': {'nctId': 'NCT00590512', 'briefTitle': 'Dietary Salt Intake and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Dietary Salt Intake and Vascular Function', 'orgStudyIdInfo': {'id': '2004P002705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Sodium', 'description': 'High sodium', 'interventionNames': ['Dietary Supplement: High sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low sodium', 'description': 'Low sodium', 'interventionNames': ['Dietary Supplement: Low sodium']}], 'interventions': [{'name': 'High sodium', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High Sodium']}, {'name': 'Low sodium', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rhonda Bentley-Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Rhonda Bentley-Lewis, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}