Hypertension Clinical Trial
— SMAL-SALTOfficial title:
Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
Verified date | February 2020 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times) - Diagnosed of hypertension for at least 3 months - No adjustment of antihypertensive agents for at least 1 month - 24h Urine sodium = 90 mmol/day - eGFR = 45 ml/min/1.73 sq.m. Exclusion Criteria: - eGFR < 45 ml/min/1.73 sq.m. - UACR > 300 mg/g - Serum potassium > 6.0 mmol/l - Serum sodium < 135 mmol/l - Unable to collect 24-hour urine |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Ramathibodi Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients with hypertensive emergency | Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents. | 8 weeks | |
Other | Questionnaire about motivation to maintain low salt diet | Scale from 0 to 10 to estimate self motivation for taking low salt strategy at baseline and at 8 weeks | after 8 weeks | |
Primary | 24-hour urinary sodium excretion | Change in 24-hour urinary sodium excretion from baseline | 8 weeks | |
Secondary | Change in systolic and diastolic blood pressure | Changes in systolic and diastolic blood pressure from baseline | 8 weeks | |
Secondary | Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds | 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. | 8 weeks | |
Secondary | Change in cardio-ankle vascular index (CAVI) | Change in cardio-ankle vascular index (CAVI) from baseline | 8 weeks |
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