Clinical Trials Directory

Trials / Unknown

UnknownNCT04286802

Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Mahidol University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICESalt-meterSalt-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.
BEHAVIORALEducationProgram dietary education by certified dietician who did not know the patients arm allocation.

Timeline

Start date
2017-07-11
Primary completion
2020-02-21
Completion
2020-02-28
First posted
2020-02-27
Last updated
2020-02-27

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT04286802. Inclusion in this directory is not an endorsement.