Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04286802
Status:
UNKNOWN
Last Update Posted:
2020-02-27
First Post:
2020-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
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': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with hypertensive emergency', 'timeFrame': '8 weeks', 'description': 'Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents.'}, {'measure': 'Questionnaire about motivation to maintain low salt diet', 'timeFrame': 'after 8 weeks', 'description': 'Scale from 0 to 10 to estimate self motivation for taking low salt strategy at baseline and at 8 weeks'}], 'primaryOutcomes': [{'measure': '24-hour urinary sodium excretion', 'timeFrame': '8 weeks', 'description': 'Change in 24-hour urinary sodium excretion from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': '8 weeks', 'description': 'Changes in systolic and diastolic blood pressure from baseline'}, {'measure': 'Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds', 'timeFrame': '8 weeks', 'description': 'Using the different saline concentration in solution. Starting from the lowest to higher concentration, the point when the patient can differentiate from distilled water is called "detection threshold", and the point that patient can identify salty taste is called "recognition" threshold.'}, {'measure': 'Change in cardio-ankle vascular index (CAVI)', 'timeFrame': '8 weeks', 'description': 'Change in cardio-ankle vascular index (CAVI) from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'uncontrolled', 'salt, excess', 'salt meter'], 'conditions': ['Hypertension', 'Salt; Excess']}, 'referencesModule': {'references': [{'pmid': '25119606', 'type': 'BACKGROUND', 'citation': "Mente A, O'Donnell MJ, Rangarajan S, McQueen MJ, Poirier P, Wielgosz A, Morrison H, Li W, Wang X, Di C, Mony P, Devanath A, Rosengren A, Oguz A, Zatonska K, Yusufali AH, Lopez-Jaramillo P, Avezum A, Ismail N, Lanas F, Puoane T, Diaz R, Kelishadi R, Iqbal R, Yusuf R, Chifamba J, Khatib R, Teo K, Yusuf S; PURE Investigators. Association of urinary sodium and potassium excretion with blood pressure. N Engl J Med. 2014 Aug 14;371(7):601-11. doi: 10.1056/NEJMoa1311989."}, {'pmid': '15343354', 'type': 'BACKGROUND', 'citation': 'Cook NR, Kumanyika SK, Cutler JA, Whelton PK; Trials of Hypertension Prevention Collaborative Research Group. Dose-response of sodium excretion and blood pressure change among overweight, nonhypertensive adults in a 3-year dietary intervention study. J Hum Hypertens. 2005 Jan;19(1):47-54. doi: 10.1038/sj.jhh.1001775.'}, {'pmid': '2573761', 'type': 'BACKGROUND', 'citation': 'MacGregor GA, Markandu ND, Sagnella GA, Singer DR, Cappuccio FP. Double-blind study of three sodium intakes and long-term effects of sodium restriction in essential hypertension. Lancet. 1989 Nov 25;2(8674):1244-7. doi: 10.1016/s0140-6736(89)91852-7.'}, {'pmid': '24967247', 'type': 'BACKGROUND', 'citation': 'Piovesana Pde M, Sampaio Kde L, Gallani MC. Association between Taste Sensitivity and Self-Reported and Objective Measures of Salt Intake among Hypertensive and Normotensive Individuals. ISRN Nutr. 2012 Oct 24;2013:301213. doi: 10.5402/2013/301213. eCollection 2013.'}, {'pmid': '19516246', 'type': 'BACKGROUND', 'citation': 'Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Many clinical studies found that salt intake over the reference level (\\>5 g/day) would result in elevated blood pressure (BP) and long-term morbidity. Dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. Salt meter is a device used to detect sodium content in daily food. It will facilitate monitoring and control of salt intake. The 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. This study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.', 'detailedDescription': "A randomized-controlled trial was conducted in hypertensive patients whose BP was uncontrolled (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite therapy or antihypertensive-naïve. Patients were randomized to receive salt meter to use in conjunction with dietary education (group A) or receive education only (group B), and were followed up for 8 weeks. Dietary education was provided by certified dietician without awareness of patients' allocation. The primary endpoint was change in 24-hour urinary sodium excretion. Changes in BP, salt taste sensitivity threshold, cardio-ankle vascular index (CAVI), as well as motivation to maintain low salt diet were also analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times)\n* Diagnosed of hypertension for at least 3 months\n* No adjustment of antihypertensive agents for at least 1 month\n* 24h Urine sodium ≥ 90 mmol/day\n* eGFR ≥ 45 ml/min/1.73 sq.m.\n\nExclusion Criteria:\n\n* eGFR \\< 45 ml/min/1.73 sq.m.\n* UACR \\> 300 mg/g\n* Serum potassium \\> 6.0 mmol/l\n* Serum sodium \\< 135 mmol/l\n* Unable to collect 24-hour urine'}, 'identificationModule': {'nctId': 'NCT04286802', 'acronym': 'SMAL-SALT', 'briefTitle': 'Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients', 'orgStudyIdInfo': {'id': '04-60-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salt-meter', 'description': 'Patients received salt-meter in conjunction with dietary education by trained dietician to help monitoring the salt content in food, as well as usual care by their primary physicians.', 'interventionNames': ['Device: Salt-meter', 'Behavioral: Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients received dietary education by trained dietician and usual care by their primary physicians.', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Salt-meter', 'type': 'DEVICE', 'description': 'Salt-meter, developed by Faculty of Engineering at Mahidol University, is a device to measure sodium chloride content in the food and reflects to user with number and symbols for easy-understanding.', 'armGroupLabels': ['Salt-meter']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Program dietary education by certified dietician who did not know the patients arm allocation.', 'armGroupLabels': ['Control', 'Salt-meter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Ramathibodi Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}