An interventional study of Salt-meter and Education in Hypertension and Salt; Excess, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Mahidol University is the lead sponsor of 744 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
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.
Device: Salt-meter · Behavioral: Education
Patients received dietary education by trained dietician and usual care by their primary physicians.
Behavioral: Education
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.
Program dietary education by certified dietician who did not know the patients arm allocation.
24-hour urinary sodium excretion
Change in 24-hour urinary sodium excretion from baseline
Time frame: 8 weeks
Change in systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure from baseline
Time frame: 8 weeks
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.
Time frame: 8 weeks
Change in cardio-ankle vascular index (CAVI)
Change in cardio-ankle vascular index (CAVI) from baseline
Time frame: 8 weeks
Number of patients with hypertensive emergency
Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents.
Time frame: 8 weeks
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
Time frame: after 8 weeks
Plan to share: No
Started Jul 2017 (actual). Primary completion is estimated for Feb 2020, 31 months after the start.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 31 months is above that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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