Hypertension, Salt; Excess
Conditions
Keywords
hypertension, uncontrolled, salt, excess, salt meter
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.
Interventions
DEVICESalt-meter
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.
BEHAVIORALEducation
Program dietary education by certified dietician who did not know the patients arm allocation.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urinary sodium excretion | 8 weeks | Change in 24-hour urinary sodium excretion from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic and diastolic blood pressure | 8 weeks | Changes in systolic and diastolic blood pressure 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. |
| Change in cardio-ankle vascular index (CAVI) | 8 weeks | Change in cardio-ankle vascular index (CAVI) from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with hypertensive emergency | 8 weeks | Number of patients documented to have hospitalisation for hypertension treatment including hypertensive emergency requiring intravenous antihypertensive agents. |
| Questionnaire about motivation to maintain low salt diet | after 8 weeks | Scale from 0 to 10 to estimate self motivation for taking low salt strategy at baseline and at 8 weeks |
Countries
Thailand
Outcome results
None listed