Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients
- Conditions
- HypertensionSalt; Excess
- Interventions
- Device: Salt-meterBehavioral: Education
- Registration Number
- NCT04286802
- Lead Sponsor
- Mahidol University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salt-meter Education 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. Salt-meter Salt-meter 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. Control Education Patients received dietary education by trained dietician and usual care by their primary physicians.
- Primary Outcome Measures
Name Time Method 24-hour urinary sodium excretion 8 weeks Change in 24-hour urinary sodium excretion from baseline
- Secondary Outcome Measures
Name Time Method Change in systolic and diastolic blood pressure 8 weeks Changes in systolic and diastolic blood pressure from baseline
Change in cardio-ankle vascular index (CAVI) 8 weeks Change in cardio-ankle vascular index (CAVI) from baseline
Improvement in salt taste sensitivity by evaluating the salt detection or recognition thresholds 8 weeks 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.
Trial Locations
- Locations (1)
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
🇹🇭Bangkok, Thailand