Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-28 @ 9:33 AM
Study NCT ID:
NCT02016404
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2013-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults
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': '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-13', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in 24-hour urinary sodium excretion', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in 24-hour urinary potassium excretion', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in body weight', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in 24-hour urinary calcium excretion', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in 24-hour urinary iodine excretion', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in 24-hour urinary creatinine excretion', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in 24-hour urinary protein', 'timeFrame': 'Change during 8 weeks of intervention'}, {'measure': 'Change in heart rate', 'timeFrame': 'Change during 8 weeks of intervention'}], 'primaryOutcomes': [{'measure': 'Change in office systolic blood pressure (SBP)', 'timeFrame': 'Change during 8 weeks of intervention', 'description': 'Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4 6 and 8.'}], 'secondaryOutcomes': [{'measure': 'Change in office diastolic blood pressure (DBP)', 'timeFrame': 'Change during 8 weeks of intervention', 'description': 'Based on repeated measurements with a digital BP device (OMRONHEM 762) using the standard protocol of WHO STEP guideline at week 0, 2, 4, 6 and 8.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['blood pressure', 'sodium', 'salt', 'low sodium high potassium salt', 'potassium', 'Vietnam', 'randomized controlled trial'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://viendinhduong.vn/home/en/Default.aspx', 'label': 'National Institute of Nutrition (NIN), Vietnam'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effects of low-sodium, high-potassium condiments and salt on blood pressure in untreated (pre)hypertensive Vietnamese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUntreated prehypertension or mild hypertension (systolic BP between 130 and 160 mmHg and/or diastolic BP between 85 and 100 mmHg) based on the mean of two measurements with a 1-week interval\n\nExclusion Criteria:\n\nDiagnosed or self-reported cardiovascular disease Diagnosed or self-reported kidney disease'}, 'identificationModule': {'nctId': 'NCT02016404', 'briefTitle': 'The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Effect of a Low Sodium-High Potassium Salt on Blood Pressure in Vietnamese Adults', 'orgStudyIdInfo': {'id': '0793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low-sodium, high-potassium salt', 'description': 'Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, mono sodium glutamate (MSG), sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation', 'interventionNames': ['Other: Low-sodium, high-potassium salt']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Regular salt', 'description': 'Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt', 'interventionNames': ['Other: Regular salt']}], 'interventions': [{'name': 'Low-sodium, high-potassium salt', 'type': 'OTHER', 'description': 'Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, MSG, sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation', 'armGroupLabels': ['Low-sodium, high-potassium salt']}, {'name': 'Regular salt', 'type': 'OTHER', 'description': 'Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt', 'armGroupLabels': ['Regular salt']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'state': 'Hai Ba Trung Dist.', 'country': 'Vietnam', 'facility': 'National Institute of Nutrition (NIN), Department of Community Nutrition', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Ha TP Do', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Nutrition, National Institute of Nutrition, Vietnam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nutrition, Vietnam', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}