Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-29 @ 3:43 PM
Study NCT ID:
NCT03154502
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Intake in Ecuadorian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2017-05-12', 'studyFirstSubmitQcDate': '2017-05-12', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary sodium excretion', 'timeFrame': '1 year', 'description': 'Amount of sodium in 24h urine collection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sodium intake', 'Urinary sodium excretion'], 'conditions': ['Dietary Habits', 'Risk Factor, Cardiovascular', 'Nutritional Disorder']}, 'descriptionModule': {'briefSummary': 'This study is aim to determine the sodium intake in Ecuadorian population that is an unknown information at present. For that, 24h urine samples will be collected from 130 subjects working either at tue USFQ or HDLV to measure sodium excretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Will be enrolled a sample of 178 adults aged 25 to 64 years. The research team, who have faculty appointments in USFQ, supervised the collection of the urine samples. We invited a broad spectrum of employees (which included health care workers, professors, and custodial staff) from both institutions to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* None\n\nExclusion Criteria:\n\n* unable to provide informed consent\n* unable to provide 24-hr urine excretion sample\n* those with a known history of heart or kidney failure, stroke, and liver disease\n* those using diuretics, multivitamins, NSADs, or prostaglandins during the last two weeks\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT03154502', 'briefTitle': 'Sodium Intake in Ecuadorian Population', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Francisco de Quito'}, 'officialTitle': 'Sodium Urinary Excretion Measurement in Ecuadorian Population', 'orgStudyIdInfo': {'id': 'HUBI-1022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Urinary sodium excretion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urinary sodium and potassium were measured using the Ion-Selective Electrode (ISE) indirect Na-K-Cl for Gen.2 (Roche Diagnostic, Switzerland).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Enrique Teran, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad San Francisco de Quito'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Francisco de Quito', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ivan Sisa', 'investigatorAffiliation': 'Universidad San Francisco de Quito'}}}}